Sleep Health

  • Sleep, Sleep Health

    Why sleep soothes distress: Neurobiology explained

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    Original Post | Caroline Pierce, Medical Express

    A study published in Nature Reviews Neuroscience by an international team including the Woolcock’s Dr. Rick Wassing examined research into sleep disorders over more than two decades to prove a good night’s sleep is the perfect remedy for emotional distress.

    Nothing we haven’t known forever, some would argue, but Dr. Wassing who has spent the past two years on the project says there’s much more to it than that.

    “What we have done with this study is explain why. We looked at studies in neurobiology, neurochemistry and clinical psychology to get a real understanding of the mechanisms underlying how sleep helps us to deal with our emotional memories.”

    What the team of researchers believe after aggregating more than 20 years’ of scientific knowledge is that the way certain neurochemicals (for example, serotonin and noradrenaline) are regulated during sleep is crucial for the processing of emotional memories and our long-term mental health.

    Chemistry and circuitry

    Serotonin is involved in many, if not almost all, aspects of learning emotional experiences. It helps us assess and understand the world around us. Noradrenaline is all about “fight or flight”—it allows us to assess and respond to danger. Both are turned off during rapid eye movement (REM) sleep and that creates this “really beautiful opportunity for the brain to engage in processes that are otherwise not doable when we are awake,” explains Dr. Wassing.

    There are two main ways we process emotional memory during sleep, he says, and they involve the brain’s hippocampus and amygdala.

    Our brains store what we learn each day. This learning is governed by the hippocampus aggregating and cataloging this new information into the “novelty” memory store as we process it. At the same time, if that new experience is emotional, the amygdala is very active and coupled with the autonomic nervous system—think racing heart, knots in your stomach, skin crawling.

    During REM sleep, our brains reactivate these new memories. It is as if the brain replays a summary of what had happened when we experienced the memory. But during REM sleep, when the noradrenergic and serotonergic systems are turned off, these memories can be moved into the “familiar” storage without experiencing the physical “fight or flight” response. That can’t happen while we’re awake or—as is the case for people with sleep disorders—when we don’t get consistent blocks of REM sleep.

    Shining a light on the brain

    Much of what we now know about the way information is processed by the brain comes from the relatively new field of optogenetics which is used to activate or inhibit very specific cell types in a neuronal network. This has allowed researchers to see what cell types and brain regions are involved in encoding emotional memories.

    According to Dr. Wassing, it has meant real breakthroughs in terms of our understanding of brain circuitry and neurobiology.

    It’s all well and good, he says, to look at neurons and receptors and circuits, but the researchers also assessed clinical psychology studies and found that their findings, especially relating to disconnecting amygdala reactivity and shutting down the autonomic nervous system, were corroborated.

    “All three levels of neuroscience align to produce the same conclusion, that the way the brain functions during REM sleep is important for processing emotional memories.”

    Making ‘good sleepers’

    So, where to now? “We know that with insomnia or other sleep disorders where people wake up from sleep a lot, we see an increased risk of developing mental health problems. Our hypothesis would be that that these awakenings from sleep lead to the fact that the noradrenergic system is not shut down for long periods of time (in fact, they might actually show enhanced activity) and that’s why these people might not be able to regulate emotional memories.”

    “The solution is to try to get a good night’s sleep, yes, but the problem is how then do we do that? We know that two out of three people with insomnia benefit from cognitive behavioral therapy for insomnia (CBTI) but that is mostly based on subjective ratings. There’s less evidence on objective sleep measures. The insomnia patient after CBTI is not necessarily a good sleeping individual, they still have some sleep disturbances but CBTI is enabling them to better deal with them.”

    “We need to critically think more about the mechanisms that regulate sleep. It’s very hard to target one system because sleep is very dynamic—the noradrenergic system shuts down during REM sleep, but it actually needs to be active during non-REM sleep so you can’t just turn it off for the entire sleep cycle.”

    “We need really creative ideas about how to design an intervention or a drug that can target these dynamics that happen during sleep and enable those systems to renormalize. We need to be targeting objective sleep and making people with insomnia good sleepers again.”

  • Sleep Apnea, Sleep Health, Sleep Study

    Recent studies show how a migraine can be predicted.

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    Sleep quality and energy levels are two of the biggest indicators of an impending migraine attack, the study showed. Get inspired by a weekly roundup on living well, made simple.  

    Wouldn’t it be helpful to have a sense of when a debilitating migraine may be on the way?

    You may be able to do so, a new study has shown.

    Migraine

    “The major finding from this study was that changes in sleep quality and energy on the prior day were related to incident headache in the next day,” said Dr. Kathleen Merikangas, principal investigator of the study that published Wednesday in the journal Neurology.

    Migraines are nothing to shake your head at, and they certainly aren’t just nuisance headaches. Chronic migraines are the leading cause of disability in people younger than 50, according to a February 2018 study.

    More symptoms than you think may be tied to your migraines

    The study team found that sleep quality and energy were important indicators of a migraine attack on the following day.

    Those who had bad sleep quality and low energy one day were more likely to have migraines the next morning, the data showed. An increase in energy and greater-than-average stress usually foretold a migraine would appear later the next day.

    “It’s a very exciting study because of how well done and how detailed and how large it is,” said Dr. Stewart Tepper, vice president of the New England Institute for Neurology and Headache in Stamford, Connecticut. Tepper was not involved in the research.

    The differences point to the importance of your circadian rhythm — which regulates your cycles of sleep and wakefulness — in how headaches manifest. The findings may inform the treatment and prevention of migraine attacks.

    Migraine prevention

    Knowing when a migraine is coming can make all the difference — especially with growing interest in treating one before it starts, Tepper said.

    “If we can identify things in the environment that people can change, then we’d like to be able to prevent the attack in the first place,” Merikangas said. “If we can do that with behavioral interventions … then they may be able to prevent it by either going to sleep to offset it or some other intervention that would prevent us from having to use medication to prevent the attack.”

    Tepper, however, said he is not so sure if changes in behavior can always prevent a migraine attack.

    FDA approves new nasal spray to treat migraine headaches in adults, Pfizer says

    A migraine attack isn’t just a headache. And warning signs such as fatigue, neck pain and sleep disturbance may be early symptoms of an attack — not only a trigger of one, he added.

    Instead, Tepper advises intervening with medication before the head pain starts in hopes of warding off any pain at all.

    How much is too much?

    It makes sense that people might be conservative about using medication for migraine pain, Tepper said.

    An older class of medications, called triptans, was associated with more migraines and a resulting chronic migraine condition if used more than 10 days in a month, he said.

    But a newer option, rimegepant — sold as Nurtec — doesn’t seem to carry the same risk.

    “There’s no downside because rimegepant has almost no side effects and is not associated with transformation into chronic migraine,” Tepper said.

    What you can do about migraines

    Your doctor can recommend pain medication to address your migraines, but it also helps to know the signs of an upcoming attack, Tepper said.

    As well as monitoring sleep, exercise and diet, Merikangas suggests finding a way to monitor stress to be able to track the indicators of a migraine.

    There are five typical signs of an oncoming migraine headache, Tepper said. Those are sensitivity to light, fatigue, neck pain, and sensitivity to noise and dizziness, he said.

    5 ways to reduce your stress this year

    Cognitive behavioral therapy is often useful to help manage the stress that can trigger migraine attacks. What’s more, taking vitamins and supplements, such as magnesium and riboflavin, can be effective in reducing migraine frequency, Kylie Petrarca, a nurse and education program director at the Association of Migraine Disorders, said in a previous CNN article.

    It isn’t just about avoiding the pain, Merikangas said.

    “It’s really important to think of the full context of our health,” she said. “By being able to characterize not just headaches, but also all these other systems, we might be able then to get a handle on causes of negative health events.”

  • Sleep Apnea, Sleep Health

    Why people should prioritize sleep quality over quantity.

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    By Analisa Novak – February 19, 2024 / 11:59 AM EST / CBS News

    When it comes to maintaining heart health, it’s not just how long you sleep — it’s how well you sleep that matters equally, if not more, said Dr. Shelby Harris, a behavioral sleep psychologist and clinical associate professor at Albert Einstein College of Medicine.

    “Poor quality sleep really can influence our heart health as well,” Harris told “CBS Mornings” in an interview during American Heart Month. 

    Harris said the body’s balance of ghrelin and leptin, hormones that regulate hunger, is also disrupted by poor sleep, leading to increased consumption of high-sugar and high-fat foods. 

    Sleep disorders like sleep apnea and insomnia are closely linked to heart health. Sleep apnea, characterized by snoring and breathing pauses, affects both men and women, though women are evaluated less frequently for it. 

    Strategies for improving sleep quality include limiting alcohol and caffeine intake, reducing screen time before bed and managing how much liquid you drink before bed. 

    “Once you have better quality then we try to work on the quantity of sleep possible,” Harris said.

    For those struggling to achieve a longer sleep duration, getting a good quality amount of sleep but shorter is ideal when you first are trying to tackle this goal. 

    “For some people, I might have them go to bed later and then I might slowly have them go to bed earlier over time as opposed to that shifting back and forth. Because that can create a lot of problems for people as well,” she said. 

    Harris said that sleeping pills and aids are not ideal for most people, but said cognitive-behavioral therapy for insomnia may offer an alternative solution to medication. 

    She said most people try four to eight sessions of the therapy and if that doesn’t work, then she would recommend sleeping aids. 

    “You work on not just the hygiene but you work on the timing of sleep. … We work on thoughts about sleep, a lot of people put pressure on themselves to sleep and they worry about what’s going to happen if they don’t sleep and so we work on that aspect,” she said. 

    Harris said dietary choices also play a role in a good night’s sleep. She said people should avoid consuming large or heavy meals, such as a big dinner, before going to bed.

    Instead, opting for a small, light snack that includes a mix of protein and carbohydrates can be beneficial. “That’s a really good mix to help you throughout the night so you don’t wake up hungry, which a lot of people do as well,” said Harris.

  • Sleep Apnea, Sleep Apnea Dentist, Sleep Health

    Five Weird Signs of Sleep Apnea

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    Original Article | By Sandee Lamotte CNN

    Sign up for CNN’s Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.CNN — 

    If you snore the house down, you may be suffering from obstructive sleep apnea, or OSA — a potentially dangerous condition in which people stop breathing for 10 seconds or more at a time.

    The condition has been linked to smaller brain volume, damage to the white matter communication pathway in the brain and even a three times higher risk of dying from any cause. If left untreated, obstructive sleep apnea puts you at higher risk for hypertension, heart disease, type 2 diabetes, depression and even an early death, according to the American Academy of Sleep Medicine.

    Yet even if you’re a rock star at snoring, you may not know you have obstructive sleep apnea unless someone tells you about your nocturnal roars. That’s why it’s important for partners and friends to speak up and encourage snorers to get professional help.

    But what if you have an odd or quirky symptom besides snoring? You and your loved ones may have no idea that you are in danger, and the condition could go undiagnosed for years.

    “Greater than 30 million people have sleep apnea in the United States, yet it’s often underdiagnosed or misdiagnosed,” said sleep specialist and pulmonologist Dr. Raj Dasgupta, an associate professor of clinical medicine at the University of Southern California’s Keck School of Medicine.

    “It’s really misdiagnosed in women versus men because women may not present with the classic, heroic snoring that men often show,” he said.

    Here are five weird signs of obstructive sleep apnea to watch for, according to Dasgupta.

    Headache as a result of sleep apnea

    Night sweats

    There are many reasons people may sweat at night. It could be too hot, especially with the persistent heat waves in the past few years due to the climate crisis. Certain medications can cause night sweats, as can cancer, thyroid issues, the flu and bacterial infections, and the onset of menopausal symptoms, according to the Mayo Clinic.

    But research has shown that about 30% of people with obstructive sleep apnea have reported night sweats, Dasgupta said.

    “It’s because your body isn’t getting enough oxygen you fall into this sympathetic fight-or-flight mode, which triggers night sweats,” he said. “The research showed people with OSA that had night sweats were also more likely to have really low oxygen levels on top of having obstructive sleep apnea.”

    Sleep apnea can cause you to wake up tired, have difficulty regulating emotions and suffer from brain fog, experts say.

    Frequent awakenings

    Many people get up at night to empty their bladders — it can be caused by alcohol overindulgence, diabetes, edema, high blood pressure, certain medications, pregnancy, prostate issues and even drinking too many fluids before bed, according to the Cleveland Clinic.

    But getting up at least two times a night to urinate — which is called nocturia — can also be a sign of obstructive sleep apnea, Dasgupta said.

    “One study found about 50% of patients with OSA had nocturia, and they noted that treatment for the sleep disorder did cut back on awakenings,” he said.

    Nevertheless, frequent nighttime urination is not commonly asked about in screening questionnaires on sleep apnea in primary provider offices, Dasgupta said.

    Teeth grinding

    Grinding or clenching teeth while sleeping is called bruxism, and it too may be a sign of obstructive sleep apnea, Dasgupta said.

    “Certainly, anxiety and other factors can cause bruxism, but a common cause is obstructive sleep apnea,” he said. “There’s a theory on why — the airway becomes obstructed, so the muscles in the mouth and jaw move to try to free the blocked airway. That’s not been proven, but it is an interesting hypothesis.”

    Most people who grind or clench their teeth use a mouthguard suggested by their dentist for protection, but it won’t protect the jaw, Dasgupta said.

    “So, a person might also develop TMJ (dysfunction), which is pain in the temporomandibular joint, and that may also lead to other issues, such as headaches,” he said.

    Morning headaches

    Studies have found a link between having obstructive sleep apnea and waking up with a headache, Dasgupta said.

    “They typically occur daily or most days of the week and may last for several hours after awakening in the morning,” he said. “The cause of the headaches is not well-established and may be multifactorial.”

    Headaches caused by obstructive sleep apnea don’t appear to lead to nausea or increased sensitivity to light and sound. Instead, they seem to be a pressing sensation on both sides of the forehead that lasts about 30 minutes, according to a June 2015 study.

    Depression, fatigue and insomnia

    Some symptoms of obstructive sleep apnea can disguise themselves as issues of mental health, brain fog or other sleep problems, Dasgupta said.

    “Sleep affects our ability to think, react, remember and solve problems,” he said. “Women especially have a tendency to underreport atypical symptoms such as insomnia, fatigue and depression.”

    If obstructive sleep apnea awakens you, it may be hard to go back to sleep. A person may suspect insomnia, not realizing that a different issue may be triggering the awakenings.

    Symptoms of daytime fatigue include a lack of motivation to accomplish everyday tasks, a lack of productivity at work, memory problems and a low interest in being social, Dasgupta said. Those are also signs of depression, so if the sleep issues aren’t brought up at a health visit, the underlying cause may be missed.

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    Dangers of Uncontrolled Sleep Apnea

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    Original Article | JohnsHopkins.org

    You’ve probably heard that regular exercise and a heart-healthy diet are the most important things you can do for your cardiovascular health. As it turns out, though, the quality of sleep you receive is also critical to your heart’s wellbeing. 

    In particular, undiagnosed sleep apnea is directly tied to an increased risk in cardiovascular and metabolic health. The scariest part? You might not even know you have this very common problem.

    “Sleep apnea happens when upper airway muscles relax during sleep and pinch off the airway, which prevents you from getting enough air. Your breathing may pause for 10 seconds or more at a time, until your reflexes kick in and you start breathing again,” explains Jonathan Jun, M.D. , a pulmonary and sleep medicine specialist at the Johns Hopkins Sleep Disorders Center.

    Sleep apnea occurs in about 3 percent of normal weight individuals but affects over 20 percent of obese people, Jun says. In general, sleep apnea affects men more than women. However, sleep apnea rates increase sharply in women after menopause. Sleep apnea is often linked to heart disease and metabolic issues like diabetes.

    What are the signs of sleep apnea?

    There are two kinds of sleep apnea: obstructive sleep apnea and central sleep apnea. Obstructive sleep apnea happens when air can’t flow into or out of the nose or mouth, although you’re trying to breathe. Central sleep apnea happens when the brain fails to send the right signals to your muscles to make you start breathing. (This type is less common.)

    “Sleep apnea may be noticed more by the bed partner than by the sleeper,” says Jun. “Your bed partner might notice that your breathing pauses, or they may complain of your loud snoring.”

    That said, snoring itself—though annoying—isn’t the same as sleep apnea. Snoring is just the vibration sound created by airway resistance. You can snore loudly and not have sleep apnea, and you may even have sleep apnea without much snoring.

    People with sleep apnea might also suffer from unexplained fatigue and mood swings, because their breathing interruptions continually wake them and prevent them from settling into a deep, nourishing sleep.

    The consequences can be significant, Jun says. “We’re talking about car accidents in the daytime, lost productivity at work, mood swings, waking up feeling groggy and falling asleep in class.”

    Other sufferers might wake up with a dry mouth, since sleep apnea tends to make you breathe with an open mouth, drying out your saliva. Some awaken with a headache, which may be caused by low oxygen or high carbon dioxide levels during sleep.

    How is Weight Control Linked to Sleep Apnea?

    “Weight control is very important. There are many studies showing that losing weight can either completely cure you of sleep apnea or at least make it less severe,” Jun says.


    Sleep apnea, cardiovascular risk and metabolism

    Several studies have shown an association between sleep apnea and problems like type 2 diabetes , strokes , heart attacks and even a shortened lifespan, says Jun. Why this connection? For one thing, obesity is common in sleep apnea patients, and obesity greatly increases risks of diabetes, stroke and heart attack, he says. “In most cases, obesity is the main culprit behind both conditions,” Jun explains.

    Still, it’s important to note that not everyone with sleep apnea is obese. Furthermore, evidence suggests an independent link between sleep apnea and diabetes. “Our lab and others have shown that sleep apnea is associated with higher risks of diabetes, independent of obesity, and that sleep apnea can increase blood sugar levels,” says Jun.

    For people who are overweight or obese, weight loss is key for treating or avoiding sleep apnea. People who accumulate fat in the neck, tongue and upper belly are especially vulnerable to getting sleep apnea. This weight reduces the diameter of the throat and pushes against the lungs, contributing to airway collapse during sleep.

    Women in particular should be careful as they age. While premenopausal women tend to put on weight in the hips and in the lower body instead of the belly, this shifts with time. Weight begins to accumulate in traditionally “male” areas like the tummy, and this leads to a greater chance of sleep apnea.

    “After menopause, hormones change and women tend to start looking like men in terms of where the weight gets put on. It’s a time to be paying attention to the risks of sleep apnea because women begin to catch up to men in the rates of apnea after menopause,” Jun says.15

    Diagnosing and treating sleep apnea for better health

    It’s important to treat sleep apnea, because it can have long-term consequences for your health. While there have been some high-profile deaths linked to sleep apnea—such as with Judge Antonin Scalia —Jun says that the true risk is from damage done over time.

    Obstructive sleep apnea can range from mild to severe, based on a measurement system called the apnea-hypopnea index (AHI). The AHI measures the number of breathing pauses that you experience per hour that you sleep.

    Obstructive sleep apnea is classified by severity:

    • Severe obstructive sleep apnea means that your AHI is greater than 30 (more than 30 episodes per hour)
    • Moderate obstructive sleep apnea means that your AHI is between 15 and 30
    • Mild obstructive sleep apnea means that your AHI is between 5 and 15

    Whether or not you need treatment for sleep apnea depends on its severity, whether or not you have symptoms such as sleepiness and other health conditions. For example, if you have risk factors for heart disease, your doctor might opt to treat you even for mild sleep apnea. On the other hand, if you have a severe case of sleep apnea, your doctor might insist on treatment even if you’re not sleepy.

    The main choice of therapy is a breathing device called a CPAP, or continuous positive airway pressure machine. A CPAP machine pipes humidified air through the nose, which creates air pressure to keep your throat open while asleep. This prevents pauses in breathing.

    “CPAP is the first-line treatment, and it’s very effective,” Jun says. A recent Johns Hopkins study looked at what happens to metabolism at night when sleep apnea patients don’t wear their CPAP. The study found that the resulting apnea caused a spike in blood sugar, heart rate, blood pressure and stress hormones—a response similar to what might happen if you were asked to get up in front of a crowd to speak. “It’s very similar to that type of a stress response,” says Jun. “I would liken sleep apnea to something like that happening on a nightly basis.”

    CPAP is not the only alternative.

    Many cannot tolerate the CPAP machine and are able to obtain the help they need from a Sleep Apnea Dental Specialist. Their use of an oral appliance has helped hundreds of thousands resolve their medical issues as they pertain to Sleep Apnea.

    Get the Medical Equipment You Need at Home

    Many studies show that regular use of CPAP or oral devices reduces blood pressure and improves wakefulness during the day. People with sleep apnea who use sleep apnea therapeutic devices also report improved quality of life. In some observational studies that compare people with apnea who seek sleep apnea remedies versus those who don’t, those seeking treatment have lower risk of stroke and heart attack and lower blood glucose, Jun notes.

    If you or your partner has noticed signs of sleep apnea, visit your doctor. A sleep specialist can order a sleep apnea test, which uses equipment to monitor your breathing and oxygen levels while you sleep. Often, you’ll visit a laboratory to spend the night for monitoring. Other times, it’s possible to use a portable, take-home kit. You’ll rest easier knowing the results.

  • Uncategorized

    CPAP Crisis Creates Chaos for Apnea Victims and Snorers!

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    Original Article | The People’s Pharmacy

    Do you know someone who snores and/or stops breathing temporarily? They could have sleep apnea. Why is there a CPAP crisis? Who is at fault?

    According to the AMA, “About 30 million people in the United States have sleep apnea, but only 6 million are diagnosed with the condition.” People with sleep apnea may stop breathing many times during the night. These episodes can last a few seconds or as long as a minute or two. They can occur dozens of times an hour. There is a CPAP crisis going on because many patients are having a hard time getting safe CPAP devices. Disclaimer: we do not know who made the CPAP device in the photo. The illustration is not intended as criticism.

    What’s It Like To Suffer Sleep Apnea?

    I have tried holding my breath while timing it with my smart phone stopwatch. It starts to get uncomfortable around 25 seconds and I have to take a breath around 30 seconds. I have a hard time imagining what it would be like to go longer than that.

    Obstructive sleep apnea (OSA) is caused by the collapse of muscles in the throat. This can block the airway. The result is reduced oxygenation of the circulating blood.

    Patients with OSA often suffer from daytime sleepiness and brain fog. That makes them more prone to accidents. They are also more likely to develop hypertension, strokes, irregular heart rhythms or heart attacks.

    Symptoms can include noisy snoring interrupted by gasping or gagging sounds. For a bed partner, this can be scary and/or annoying. It’s hard to sleep when the person nearby is “sawing wood” and intermittently gasping for air. People with OSA may also complain about frequent nighttime trips to the bathroom to pee, morning headaches, daytime irritability and “cotton mouth” upon awakening.

    Treating OSA and the CPAP Crisis:

    To treat sleep apnea, doctors prescribe machines that pump air in a continuous stream that can help keep the airways open. They are called CPAP devices, for continuous positive airway pressure. Some people find the devices noisy and uncomfortable. You have to wear a kind of face mask that pushes air into the throat and lungs.

    Others find the devices improve the quality of their lives. Here is just one of the hundreds of messages we have received on our website:

    Jerry reports that CPAP made a difference:

    “Sleep apnea is a medical condition that can cause frequent nighttime urination. After being diagnosed with severe obstructive sleep apnea, I was treated using CPAP therapy.

    “The very first night after getting my CPAP machine I slept for a full 7 hours. Before treatment, I was waking and passing large amounts of urine every 1-2 hours. My blood pressure went from high to normal, and my heart rate during exercise dropped by 20 heartbeats.”

    The CPAP Crisis Is Creating Chaos:

    Needless to say, people with serious sleep apnea rely on these machines and are well aware that their lives depend on them. Just imagine the panic they might feel if their machines were no longer available.

    That has happened to far too many patients over the last year, as the company that dominates the industry, Philips Respironics, fumbled a recall of faulty CPAP devices.

    Here is what one reader wrote us about the CPAP crisis:

    “My husband has sleep apnea, so he has used a CPAP for over 12 years. Recently his machine stopped working. When he contacted his supplier, he was told his machine had been recalled and he would have to wait for a replacement. They advised him to contact the manufacturer, Philips.

    “He called Philips, and after following the instructions to restart the machine, was told it was not working. That was July 11. We had just gotten home from the ER where we both tested positive for COVID and received infusions. So he has been without his CPAP since then.

    Anxiety interferes with sleep:

    “He is very aware of the dangers of not using the CPAP machine and has been sleeping very uncomfortably since then. I have been anxious as well, just listening to his snoring. Here’s hoping he does not stop breathing, as he used to do before getting the CPAP.

    “I have heard that it can take up to a year to get a replacement. Surely, he is not alone in this situation. What is a person with sleep apnea supposed to do? A person at his pulmonologist’s office said they are currently diagnosing new patients with severe sleep apnea. These patients are being placed on waiting lists.

    “To my mind, this situation is similar to not having baby formula available. Apparently, there are currently just two companies in the USA who manufacture CPAP devices. What can patients do without this important appliance? Doctors warn that using the machine every night is of critical importance. What can be done to help so many people in need?

    “I am hoping that sleep apnea patients can soon get the machines they desperately need for a good safe night’s sleep.”

    How Has the FDA Fumbled the CPAP Crisis?

    Our reader is right to compare the situation with CPAP machines to the baby formula shortage. Both result from the FDA’s inadequate oversight. In our opinion, the FDA has fumbled a few too many oversight responsibilities.

    That’s not just our opinion. An article in JAMA Internal Medicine, July 26, 2021 reviewed the FDA’s oversight of MAUDE (Manufacturer and User Facility Device Experience). The agency relies on device manufacturers, distributors, physicians, patients, hospitals and other health care facilities to submit reports of problems. Unfortunately, the FDA only pays attention to deaths, rather than all serious complaints.

    The analysis in JAMA Internal Medicine points out that:

    “For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23%, suggesting that approximately 31,552 reports in our sample had deaths that were classified in other categories.”

    If the FDA ignores serious complaints and overlooks deaths with misleading codes, it risks leaving flawed medical devices on the market long past their “use by” date. You can read more about the agency’s fumbling and bumbling at this link.

    What Went Wrong With CPAP Machines”

    On July 29, 2021, the FDA issued an announcement about problems with Philips Respironics BiPap and CPAP machines.

    On May 19, 2022 the agency updated its warning:

    “Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.”

    The Washington Post reported on July 29, 2022 that:

    “Today, those machines are at the heart of one of the biggest medical device debacles in decades.”

    “If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. The Food and Drug Administration classified the recall as the most serious type, saying “use of these devices may cause serious injuries or deaths.”

    According to the Washington Post, millions of patients have been left in limbo while they wait for their devices to be repaired or replaced.

    “In May, the FDA announced it had received 21,000 reports, including 124 deaths, concerning the breakdown of the polyester-based polyurethane foam in sleep apnea machines and ventilators during the past year — a sharp increase from 30 the previous decade.”

    How long has the maker of CPAP machines known there was a problem? Why didn’t the FDA discover this problem on its own? What should it do about the CPAP crisis?

    Some Recommendations from The People’s Pharmacy:

    Here are some of our suggestions:

    • 1) The president should invoke the Defense Production Act to increase the manufacture of chips specifically for these medical devices.
    • 2) Philips Respironics should prioritize delivering CPAP machines to people who are most vulnerable. The company should also communicate directly to every patient.
    • 3) The FDA should be more proactive regarding critical medical devices so that a life-threatening shortage of this sort never happens again.

    What Do You Think?

    We would love to read your thoughts about the CPAP crisis in the comment section below. Do you know someone who snores and has obstructive sleep apnea? Have they ever used a CPAP machine? Has their device been recalled? What are they doing now?

    If you think this article has merit, please send it to friends and family. We suspect that someone you know snores, has a sleep apnea and/or has a CPAP-type machine. They (and their health care providers) may not know about the problems with these devices. It’s super easy to share. Just scroll to the top of the page and click on the icons for email, Twitter and Facebook.

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