Fda Authorizes Marketing Of Novel Device To Reduce Snoring And Mild Obstructive Sleep Apnea In Patients 18 Years And Older
- For Immediate Release:
- February 05, 2021
Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.
The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of 6?weeks, and once a week thereafter.
The FDA granted the marketing authorization to Signifier Medical Technologies, LLC.
Treating Obstructive Sleep Apnea Improves Essential Hypertension And Quality Of Life
DONALD S. SILVERBERG, M.D., ADRIAN IAINA, M.D., Tel Aviv Medical Center, Tel Aviv, Israel
ARIE OKSENBERG, PH.D., Loewenstein Hospital Rehabilitation Center, Raanana, Israel
Am Fam Physician. 2002 Jan 15;65:229-237.
Obstructive sleep apnea , defined as an average of at least 10 apneic and hypopneic episodes per sleep hour, is a common sleep-related breathing disorder that leads to excessive daytime sleepiness because of marked fragmentation of sleep. Patients are frequently not diagnosed despite years of being symptomatic , because physicians do not routinely look for the disorder. Additionally, the role of OSA in the production of essential hypertension is frequently not appreciated.1–4 The purpose of this article is to demonstrate how commonly OSA occurs, how the quality of patients’ lives can improve with successful treatment, and how the disorder is related to EH.
OSA is characterized by a repetitive partial or complete closing of, apneas or hypopneas that last a minimum of 10 seconds are considered clinically significant, although they usually last from 20 to 30 seconds and can last more than one minute. Most of these episodes end when the patient wakes up slightly, almost always without being aware of it. This “arousal response” causes the airway to reopen. In severe cases, the cycle of opening and closing of the pharynx can recur 400 to 600 times a night.
What Are The Ways To Prevent Obstructive Sleep Apnea In Children & Does It Reoccur
Sleep apnea is a disorder that affects you to cease breathing for short cycles while you’re sleeping. To be more precise, patients with obstructive sleep apnea experience obstructed or restricted breathing for periods of 10 seconds or longer during sleep. Persons with this condition don’t take sufficient oxygen. This causes them to gasp and often wake up.
This disorder affects millions of American adults, and the prevalence of the disorder has been growing over the last few decades. Obstructive sleep apnea in children leads to sleep deprivation and other health complications on the body.
Weight Loss Breathing Devices Still Best For Treating Obstructive Sleep Apnea
Experts continue to emphasize the importance of lifestyle modifications—especially weight loss—for treating obstructive sleep apnea.
Obstructive sleep apnea is a disorder in which the airway becomes blocked during sleep, interrupting breathing—sometimes dozens of times during a single night. Having obstructive sleep apnea puts you at risk for a number of other conditions, including high blood pressure and stroke.
How Corrective Jaw Surgery Can Cure Sleep Apnea And Enhance Appearance
Patients often turn to corrective jaw surgery to correct irregularities in their jaw and teeth to improve chewing, speaking, and appearance. However, an additional condition that many people don’t realize corrective jaw surgery can improve is obstructive sleep apnea.
Obstructive sleep apnea, or when people repeatedly stop breathing while asleep, can occur when jaw bones aren’t properly working in tandem with muscles around the face and neck to support the tongue and airway. This can cause symptoms such as:
- Excessive fatigue
- Morning headache
Corrective jaw surgery can be a solution for patients with these problems. The surgery can realign the jaws and teeth, open up the airway, and relieve patients of their symptoms—so much so that some patients say their entire family sleeps better upon their snoring being corrected.
What Is Sleep Apnea Symptoms Causes Diagnosis Treatment And Prevention
Correctly identifying and treating sleep apnea can also play a crucial role in public safety, says Ronald Chervin, MD, immediate past president of the American Academy of Sleep Medicine and a professor of sleep medicine, professor of neurology, and the director of the Sleep Disorders Centers at the University of Michigan in Ann Arbor.
“Sleep apnea is a public health problem,” he says.
What Are The Ways To Prevent Obstructive Sleep Apnea In Children
Sleep apnea is a serious and sometimes life-threatening condition because it continuously affects the ability to sleep well thus resulting in severe health hazards when left untreated. A new study states that losing your fat or maintaining a healthy weight can alleviate symptoms of obstructive sleep apnea.
Early identification and therapy are vital to prevent problems that can influence children’s development, cognitive advancement, and performance. The primary cause of obstructive sleep apnea is overweight or obesity problems. Clinical studies show that 60% of obese children are diagnosed with this disorder and are typically characterized by snoring, recurrent partial or complete obstruction of the upper airway.1
Therefore, when you are exploring ways to prevent or stay away from this condition there are few things that need to be taken into consideration
Maintain A Healthy Weight – Parents find themselves in a difficult and confusing position when they are told their child needs to lose weight when he/she diagnosed with health complications. Obesity and extra weight are harmful to almost EVERY organ in the body. Being overweight can lead to many diseases, including heart disease, diabetes, high blood pressure, stroke, asthma and even some types of cancer. To help your kid sustain a healthy weight, help them stabilize the calories they eat from diets and drinks with calories exhausted through physical activity and normal growth.
What Are The Prevention Measures For Obstructive Sleep Apnea
Patients should restrict their body positions during sleep. SDB is worse in the supine position, and some patients have apnea only in this position. Preventing the patient from assuming the supine position by using devices such as a snore ball or a gravity-activated position monitor may be useful. However, these devices are cumbersome and appear to benefit only those patients with mild OSA.
Patients with marked obesity may benefit from sleeping in an upright position. Additionally, the FDA has approved a specially designed pillow for the treatment of snoring and mild OSA, which maintains the patient’s head and neck position during sleep to optimize UA patency.
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 . 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
- 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
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We provide high quality, individualized care for patients of all ages where you feel most comfortable – your home or community. Our services and equipment are designed to help you regain and retain a level of independence.
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.
Not very relaxing, right? Luckily, it’s treatable.
Pathophysiology Of Developing Af In Patients With Osa
Mechanisms linked to the development of AF in patients with OSA include thehemodynamic changes occurring during the apneic episodes. Hypoxemia andhypercapnia during episodes of hypopnea/apnea leads to tachycardia andhypertension. These changes are accompanied by increased myocardial oxygendemand, despite the restricted supply of oxygen during these episodes. Thisleads to myocardial injury and fibrosis, which promote the development ofAF,. Episodes of hypopnea/apnea and post apneicreoxygenation also lead to oxidative stress, which contributes to the remodelingof the myocardium. OSA isassociated with higher levels of CRP and IL-6, however the use of CPAP therapy has beenshown to decrease these inflammatory markers in patients with OSA.
OSA is also associated with atrial enlargement, conduction abnormalities, andprolonged sinus node recovery time. This structural and electrical remodeling contributes tothe development of AF.
How Much Weight Do I Need To Lose To Stop Sleep Apnea
If overweight and obese people lose weight, it would make both sleep apnea and other health problems go away. Losing just 10% of body weight can have a big effect on sleep apnea symptoms. In some cases, losing a significant amount of weight can even cure the condition.
Learn About Other Precautions To Help You Stay Safe
Sleep apnea can increase your risks of complications if you are having surgery, and it can affect your ability to drive.
- Before surgery. If you are having any type of surgery that requires medicine to put you to sleep or for pain management, let your surgeon and doctors know that you have sleep apnea. They might have to take extra steps to make sure that your upper airway stays open during the surgery and when selecting your pain medicines.
- Driving precautions. Undiagnosed and untreated sleep apnea can decrease learning capabilities, slow down decision making, and decrease attention span, which can result in drowsy driving.
Sleep Apnea Vs Snoring: How To Tell The Difference
Not everyone who has sleep apnea necessarily snores, but most people do. While snoring from time to time is pretty common for adults and not usually harmful, excessive and very loud snoring that interrupts normal sleep and your quality of life is a serious problem. How can you tell the difference between sleep apnea and simply “normal snoring”?
First and foremost, your spouse or partner might be able to help clue you in on your own sleeping habits. Do they notice you snoring loud enough that it wakes them up repeatedly and disturbs their sleep quality too? Do they report that you’re stopping and starting breathing, waking up startled or gasping for air? If you’re struggling with sleep apnea, your snoring might take on other forms that aren’t normal, including strong gasping, shaking and choking sounds that wake you up suddenly. If no one sleeps close enough to you to report symptoms, try using a tape recorder to track your own breathing sounds while you’re sleeping.
Normal snoring also doesn’t tend to make people tired, distracted and irritable during the day because it doesn’t usually impair sleep quality. Chronic fatigue is one of the biggest signs of poor sleep quality due to sleep disturbances like sleep apnea. If you notice changes in your concentration, mood, memory, weight, appetite and personality , then you might have sleep apnea.
Final Thoughts on Sleep Apnea
Who Provides Treatment For Obstructive Sleep Apnea
Care for people with sleep apnea is typically directed by a medical doctor, and their health care team may include a respiratory therapist, sleep technician, dentist, dietician, and/or physical therapist. Primary care physicians as well as gastroenterologists, pulmonologists, cardiologists, otolaryngologists , and surgeons may be involved in planning and monitoring a patient’s treatment plan.
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Treatment For Obstructed Sleep Apnoea For Children
Large tonsils and adenoids can block the throat during sleep and cause snoring. In some cases, this is bad enough to cause poor quality sleep and severe breathing problems, called obstructive sleep apnoea .
The more severe your child’s OSA is, the more likely it is that removing the tonsils and adenoids will help improve their health’s and quality of life.
Tonsillectomy is most likely to improve OSA for children with noisy breathing while asleep most nights and at least two other related problems present even when they not sick such as:
- struggling to breathe while asleep
- pauses in breathing during sleep
- gasping or choking during sleep
- persistent daytime mouth breathing
- daytime tiredness, concentration or behaviour problems not related to other causes
However, mild problems can get better as a child gets older without surgery. Two out of three children with mild sleep apnoea get better over six months without surgery. Waiting six months may be a good option if you are not sure.
Safer Care Victoria has developed a Making a decision about tonsillectomy fact sheet to support parents in making an informed decision about tonsillectomy for their child together with their child’s doctor.
There are also fact sheets to help families understand what to do before a child’s day of tonsil surgery, what to expect and how to care for their child after this surgery.
See the fact sheets here:
Other Positive Airway Pressure Breathing Devices
In addition to CPAP, there are other devices that a sleep specialist may recommend for sleep apnea treatment.
Expiratory positive airway pressure single-use devices fit over the nostrils to help keep the airway open and are smaller, less intrusive than CPAP machines. These may benefit people with mild-to-moderate obstructive sleep apnea.
Bilevel positive airway pressure devices can be used for those who are unable to adapt to using CPAP, or for central sleep apnea sufferers who need assistance for a weak breathing pattern. This device automatically adjusts the pressure while you’re sleeping, providing more pressure when you inhale, less when you exhale. Some BiPAP devices also automatically deliver a breath if the mask detects that you haven’t taken one for a certain number of seconds.
Adaptive servo-ventilation devices can be used for treating central sleep apnea as well as obstructive sleep apnea. The ASV device stores information about your normal breathing pattern and automatically uses airflow pressure to prevent pauses in your breathing while you’re asleep.
Healthy Lifestyle Changes To Prevent Sleep Apnea
If you are concerned about having risk factors for developing sleep apnea, ask your doctor to recommend healthy lifestyle changes, including eating a heart-healthy diet, aiming for a healthy weight, quitting smoking, and limiting alcohol intake. Your doctor may recommend that you sleep on your side and adopt healthy sleep habits such as getting the recommended amount of sleep.
Treatment And Medication Options For Sleep Apnea
- Eat right, exercise, and lose weight. Fill your plate with heart-healthy options like vegetables, fruits, and whole grains and get plenty of exercise. Adopting these healthy habits can help you maintain a healthy weight, which is important because obesity can increase your risk for sleep apnea.
- Stop smoking. Smoking may increase upper airway inflammation and reduce function.
- Avoid alcohol and certain medications. Don’t take sedatives, opioids, or ,and try not to drink, especially close to bedtime, as these substances can relax the muscles in the back of your throat and potentially further interfere with breathing, according to Sleep Foundation.
- Do not sleep on your back. Sleeping on your back can increase the likelihood that your tongue and soft palate will fall back into your airway, causing airway obstruction, snoring, and sleep apnea.
RELATED: Weight Loss Plans That Work
Continuous Positive Airway Pressure The most common treatment is a CPAP machine, which is a device you can use at home that gently forces pressurized air through a mask you wear over your nose and mouth into your airway to keep it open while you sleep at night. CPAP has been shown to be effective in treating sleep apnea.
Why Sleep Health Is A Big Part Of Women’s Health
Sleep apnea symptomsSleep
They measured sleep apnea severity based on the apnea-hypopnea index — which is the number of pauses in breathing per hour of sleep — during both REM and non-REM sleep and found that twice as many men as women had a top AHI score of 15 during non-REM sleep. But during the REM phase of sleep, the same number of men and women had a high AHI score. This was important, according to the researchers, because this is the number that doctors believe is the best predictor of a person’s risk for developing hypertension and cardiovascular disease.
How To Prevent Sleep Apnea: 7 Lifestyle Changes
Sleep apnea is a chronic sleep disorder that can wreak havoc on a person’s daily life. If you have a loved one with sleep apnea, or if you think you might be at risk, here are seven lifestyle changes you can make right now to prevent sleep apnea. Note that if you’re already diagnosed with sleep apnea, these preventative measures do not take the place of a doctor’s treatment.
Is Obstructive Sleep Apnea A Recurring Disorder
Patients with untreated obstructive sleep apnea have a higher recurrence of atrial fibrillation after cardioversion than patients without a polysomnographic diagnosis of sleep apnea. Appropriate treatment with CPAP in Obstructive Sleep Apnea in children is often related to lower recurrence of atrial fibrillation.
Weight gain is one of the most critical factors of relapse of obstructive sleep apnea after medical therapy. Also, in patients who were using CPAP, recurrence was noticed when they tried to withdraw the device. In 70% of the cases, obstructive sleep apnea recurred after five nights of CPAP withdrawal. Upper airway collapsibility and neuromuscular tone, pharyngeal edema and infection, nerve breathing drive, sleep phases, and posture may perform a part.
In addition, according to a new study Obstructive Sleep Apnea in children increases the risk for Pulmonary embolism recurrence. Aging, lack of exercises and overweight problems are few of the underlying conditions causing the relapse of recurrence of obstructive sleep apnea.
Although achieving and sustaining weight reduction are challenging, the outcomes are very helpful when children can do so. Besides, following a better lifestyle and effective home remedies can help prevent and manage the condition.4,5
What Is Sleep Apnea And How Can It Be Prevented
It is never too late to start living a healthier lifestyle to prevent sleep apnea and other serious health conditions from developing.
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.
Ruling Out Other Medical Reasons Or Conditions
Your doctor may order the following tests to help rule out other medical conditions that can cause sleep apnea:
- Blood tests to check the levels of certain hormones and to rule out endocrine disorders that could be contributing to sleep apnea. Thyroid hormone can rule out hypothyroidism. Growth hormone tests can rule out acromegaly. Total testosterone and dehydroepiandrosterone sulphate tests can help rule out polycystic ovary syndrome .
- Pelvic ultrasound to examine the ovaries and detect cysts. This can rule out PCOS.
Your doctor will also want to know whether you are using medicines, such as opioids, that could be affecting your sleep or causing breathing symptoms of sleep apnea. Your doctor may want to know whether you have traveled recently to altitudes greater than 6,000 feet, because these low-oxygen environments can cause symptoms of sleep apnea for a few weeks after traveling.
Obstructive Sleep Apnea Classified By Severity
Obstructive sleep apnea causes apneic events that reduce blood flow to the brain. When this happens, the brain gets a signal to partially awaken because the body needs to breathe.
After you wake up, you might experience loud gasping, choking, or snorting sounds because you are taking breaths to fight the obstruction. Once the breath is taken and the brain returns back to sleep mode, the process starts up again. This process might occur a few times a night or up to 100 times, depending on the severity of the apnea.???
OSA is classified as mild, moderate, or severe.???
- Mild OSA: People with mild OSA have 5–14 breathing apneic events in one hour.
- Moderate OSA: With moderate OSA, a sufferer will experience 15–30 episodes in an hour.
- Severe OSA: The person will experience 30 or more episodes in an hour.
Even though mild sleep apnea causes fewer interruptions than moderate or severe OSA, 5 to 14 interruptions in breathing per hour are still a lot for your sleep to be interrupted and for you to stop breathing.
How We Chose The Best Pillows For Sleep Apnea
When choosing pillows to feature on this list, we opted for pillows that:
- Are good for stomach and side sleeping.Research suggests that many cases of obstructive sleep apnea happen because of a person’s sleeping position. In these cases, a simple change to your stomach or side — rather than your back — can make a difference in symptoms.
- Can help elevate the head. Sleeping on your back can make sleep apnea worse . However, if you can only fall asleep while resting on your back, elevating your upper body with something like a wedge pillow may help.
- Are CPAP machine compatible. If you have moderate or severe sleep apnea, you may have a difficult time sleeping while wearing a CPAP mask. Some pillows are designed to accommodate the bulky masks and prevent them from digging into your face.
- Have rave reviews. We checked customer feedback to make sure each pillow is rated highly.
- Are adjustable. If you’re lying on your stomach, a soft, thin pillow is usually most comfortable. For side sleepers, a firm or extra-firm pillow is key. That said, personal preference plays a part, too. That’s why we’ve included a couple of adjustable pillows that allow you to remove fill layers to accommodate your preferred sleeping position and pillow feel.