Category Archives: Sleep News (RSS)

Side Effects of CPAP and How to Deal with Them0

90 Million Americans Will Be Snoring This Valentines Day0

Insomnia and Alzheimer’s Disease: A New Randomized Trial Provides Data on the Efficacy and Safety of BELSOMRA (suvorexant) C-IV0

The Merck-funded trial brought patients into the sleep lab to determine whether total sleep time and wake after sleep onset improved.

When confronted with the progressive cognitive decline of Alzheimer’s disease (AD), doctors could be forgiven for overlooking the less devastating sleep-related symptoms that many AD patients also experience. Yet disordered sleep—which occurs in 39% of AD dementia patients—has insidious consequences in this population. Insomnia impacts quality of life for AD patients and AD caregivers. It is even a contributing factor to early institutionalization for patients.

Behavioral sleep strategies, such as regular wake times and morning sun exposure, are firstline interventions, and give AD patients well-planned opportunities for healthy sleep and wake. But when nondrug therapies don’t provide enough relief, safe, efficacious drug therapies for this cognitively fragile population have been hard to come by. A 2011 systematic review on the treatment of sleep disturbance in AD found mixed results for melatonin, limited overall impacts of acetylcholinesterase inhibitors, and “the evidence for sedative-hypnotics and second generation antipsychotics on sleep disturbance in dementia appears to be associated with sedation and attenuating the behavioral and other neuropsychiatric manifestations of dementia rather than a primary effect on sleep.”

This year, a team of researchers funded by biopharmaceutical company Merck published results of a randomized, double‐blind, placebo‐controlled, parallel-group, multi-site trial testing the efficacy and safety of suvorexant (marketed by Merck as BELSOMRA) for treating insomnia in patients with mild‐to‐moderate probable AD dementia. Because suvorexant acts through a unique mechanism—orexin-mediated wake signaling—”we thought it might demonstrate favorable efficacy and safety,” says lead author W. Joseph Herring, MD, PhD, associate vice president, Global Clinical Research, Neuroscience, Merck Research Laboratories.

Suvorexant is an orexin receptor antagonist that enables sleep to occur via selective antagonism of wake‐promoting endogenous orexin neuropeptides at orexin receptors OX1R and OX2R. A key question for clinicians is whether suvorexant’s safety and efficacy profile for treating insomnia in non‐demented elders is similar for treating the sleep disorder in those with AD, considering the brain changes that occur in AD, including possible dysregulation of orexin signaling.

The results of this study indicate that “functional orexin signaling is sufficiently retained” in mild-to-moderate AD, Herring says. At week 4, suvorexant improved total sleep time by a mean difference of 28 minutes compared to placebo and improved wake upon sleep onset, both assessed by in-lab polysomnography. What’s more, patients taking suvorexant were twice as likely to show an improvement of at least 60 minutes in total sleep time. Suvorexant also showed no evidence for worsening of the underlying cognitive impairment.

The U.S. Food and Drug Administration this month approved Merck’s request to add a section to BELSOMRA’s prescribing information about the study’s findings, making BELSOMRA the only sleep medication with prescribing information that includes its efficacy and safety in patients with mild-to-moderate Alzheimer’s disease.

In the study, suvorexant did not appear to alter the underlying sleep architecture profile. “What we’ve observed is proportionally appropriate increases across all the sleep stages, for the total sleep time increases,” Herring says, adding that it’s a “highly valuable attribute” of the drug to not perturb the inherent pattern of cycling between REM and non-REM stages.

Since the treatment duration in this trial was 1 month, the investigators “don’t have data to directly address the question for how long [this population] may continue to benefit beyond that time frame,” Herring says. “However the nature of the condition of insomnia is that it persists.” A Merck-funded 1-year treatment study published in 2014 found discontinuing suvorexant to be linked with the return of the insomnia, which suggests a “sustained benefit of treatment, at least in that setting,” Herring says.

Similar to studies of suvorexant in other populations, drowsiness was the most common adverse event in the AD population (4.2% of patients in the suvorexant group and 1.4% of patients in the placebo group). When asked about whether somnolence is of particular risk to people with Alzheimer’s disease, Herring responds, “At baseline, patients were sleeping less than 5 hours a night—a woefully low amount of sleep. There are also risks associated with short-sleep duration, including detrimental effects on cognition.” BELSOMRA’s product labeling does alert prescribers to the risk of somnolence, he notes.

W. Joseph Herring, MD, PhD

W. Joseph Herring, MD, PhD

Analyzing change to fall risk is always important in research conducted with a geriatric population. In this study, 4 falls occurred (in 3 patients) in the suvorexant group and no patients in the placebo group. During the run‐in period, 3 falls occurred in patients receiving placebo. While blinded to treatment, the investigators advised that none of the falls were drug‐related. “It’s important to acknowledge that the elderly are more prone to falls,” Herring says. “In a previous randomized clinical trial with BELSOMRA, elderly participants did not experience an increased rate of falls.”

In addition to providing answers about suvorexant’s safety and efficacy in Alzheimer’s patients, this study also contributes to the understanding of whether insomnia in AD is the same as insomnia in patients without dementia—a matter of ongoing debate. “It hasn’t been very well-characterized,” Herring says, noting that some studies refer to probable insomnia in AD as “disrupted sleep.” Because this study used the American Psychiatric Association’s DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria to identify AD patients with insomnia, it supports that insomnia in AD has characteristics similar to those of insomnia in otherwise healthy populations.

With more data available on how to treat insomnia in Alzheimer’s disease patients, perhaps more doctors will directly address sleep concerns moving forward. Herring says, “We hope the attention this trial is receiving will help to improve the recognition of insomnia in AD.”

Sree Roy is editor of Sleep Review.

A Tongue Pacemaker for Sleep Apnea: High Tech Hope or Hype?0

Every few years, a revolutionary way of treating OSA comes out. Nineteen eighty (1981) was a pivotal year in sleep medicine when Dr. Colin Sullivan reported reversing a vacuum cleaner motor to provide positive pressure through a makeshift mask to treat severe obstructive sleep apnea. Dr. Shiro Fujita also described a palatal operation to treat obstructive sleep apnea in 1981. Later on, oral appliances were also introduced. Over the years, advances were made with positive air pressure as well as with multi-level soft tissue and jaw procedures.

In 2014, the Inspire hypoglossal nerve stimulation procedure received FDA approval for patients in the United States. In their pivotal trial with results published in the New England Journal of Medicine in 2014, they reported a 68% drop in the average apnea hypopnea index (AHI), 70% drop in the oxygen desaturation index (ODI), and with an overall “response” rate of 66% (more than 50% drop in the AHI and less than 20).

Having been involved years prior with similar technology through another company called Apnex, I was pleased to see that this technology had progressed to the point of being available to the general public. Due to the volatile nature of medical high-tech start-up companies, I was cautiously waiting to see how they would do and see what the results would show in the real world on a long term basis. In 2018, a  group of surgeons performing this procedure published their 5 year outcomes. One hundred and twenty six patients were followed for 5 years, and 97 were included in the study, with 71 available sleep studies. Comparing from baseline to 12, 36 and 60 months, improvements across all measurements remained stable. The pre-treatment AHI was 32, dropping to 15, 11 and 12, at 12, 36 and 60 months, respectively. The functional outcome of sleep questionnaire (FOSQ, a validated sleep quality of life tool) increased significantly from 14 to 17, 17 and 18. The Epworth Sleepiness Scale dropped from 11.6 to 7 at all follow-up periods. Now, this procedure is being performed at over 300 centers in the United States and more and more insurance carriers are covering it, usually after a preauthorization process.

Technically, the pacemaker is implanted under the skin beneath the right collarbone, as opposed to a heart pacemaker, which is implanted on the left side. It’s a similar sized container. A small incision is made under the right chin, and the nerve that supplies the tongue (hypoglossal nerve) is exposed. This technique is very similar to a common procedure we perform in our field to remove the submandibular gland for stones, infections, or cancer. Once the nerve is identified under a microscope, a nerve stimulator cuff is placed around a specific area of the nerve that protrudes the tongue. Another small incision is made on the right ribcage and a breathing sensor is placed. The tongue nerve cuff and respiratory sensor are then connected to the chest neurostimulator under the skin. Essentially, it senses when you make an effort to breathe during sleep, and stimulates your tongue to keep your throat open. There is a remote control that can control the setting and timing functions as well.

These results are in line with published data for multi-level soft tissue procedures. However, the recovery process is faster with significantly less pain and discomfort. It is performed as same day surgery, and the device is activated at one month post-op and fine tuned in the sleep lab in 2 months. The battery lasts 11 years, and can be changed in an outpatient procedure.

Although this procedure may sound like a magic bullet for people with sleep apnea, it’s not for everyone. There are a handful of inclusion criteria to be eligible for this procedure. First of all, you must have tried and refused CPAP. The AHI has to be moderate or severe (AHI between 15 to 65). Your sleep test has to be performed within the past 2 years. Your BMI has to be under 32. Lastly, you’ll need to undergo drug induced sleep endoscopy to see the pattern of soft palate collapse. If it collapses in the front to back manner, then you’re a candidate. If it closes in a concentric or circumferential manner, you’re not a candidate. The main reason for this last criteria is that when the tongue protrudes forward, it pulls on a muscle attached to the side of the tongue that connects to the soft palate, called the palatoglossus muscle. If the soft palate is too floppy, relaxed or redundant, the tongue movement won’t open the soft palate as well. 

What this means is that this procedure will apply to only a small minority of sleep apnea sufferers, excluding most overweight people. Additionally, you have to be willing to be implanted with a device, something not everyone will feel comfortable with. I counsel inquiring patients that the success rate is good, but not perfect, with about 10% of people not getting the full benefits desired. There is also the potential risk of anesthesia and surgery in general. 

If you can’t tolerate CPAP and you meet the other criteria and you’re willing to consider an implantable pacemaker, then this option may be a good one. To find a surgeon or sleep lab that performs this procedure, visit Inspiresleep.com. Only a face-to face consultation can determine if you’re officially a candidate. 

The post A Tongue Pacemaker for Sleep Apnea: High Tech Hope or Hype? appeared first on Doctor Steven Y. Park, MD | New York, NY | Integrative Solutions for Obstructive Sleep Apnea, Upper Airway Resistance Syndrome, and Snoring.

6 Ways to Improve Your Sleep0

Derron’s Weight Loss Journey0

Derron Golden once weighed 360 pounds. As a result, he suffered from severe obstructive sleep apnea, high cholesterol, back pain, shortness of breath upon exertion, and type 2 diabetes, reports Beth Israel Deaconess Medical Center.

Derron began increasing his exercise, going to the gym and playing basketball multiple times a week. His sleep apnea and back pain improved and he even stopped taking medication for diabetes.

And then came the marathon, which he completed last April in under six hours, an achievement he’s very proud of. Although he won’t be running the race in 2020 because he “doesn’t want to endure that pain again,” Derron has other healthy plans for the future.

Get the full story at www.bidmc.org

6 Facts about Sleep and Your Valentine0

Is a Weighted Blanket for You?0

Do you want to get better sleep? If so, you’ve probably read everything there is to know about getting a good night’s rest. Avoid blue light when it’s time to go to bed. Go see a doctor if you have sleep apnea or another sleep disorder. If you’ve tried everything, go see a therapist. However, you may not be entirely in the loop when it comes to getting good sleep, and one of the newer ways to get a good night’s rest is to get a weighted blanket.

Sleep Apnea and Your Dental Health0

Did you know sleep apnea can cause dental problems adding to health issues? Saliva is the mouth’s first line of defense against tooth decay. It washes away food debris, neutralizes destructive acids caused by bacteria and helps keep the soft and hard tissues of the mouth in good condition.

Snoring is a common symptom of sleep apnea that causes dry mouth leading to oral bacterial infections or other dental issues.

Bruxism (aka grinding teeth) diminishes not only your quality of sleep but harms the enamel making your teeth vulnerable to tooth decay. It can also lead to TMJ (temporomandibular joint disorder) which causes migraines, oral numbness or pain, or pinched nerves. Add in any missing teeth and grinding can increase bringing frequent loss of sleep.

Vibroacoustic Therapy Shows Brain and Sleep Quality Benefits in Clinical Trial for Insomnia0

Many people find it easier to sleep in a car or a train because of the vibration and noise that helps “rock” them to sleep. But a more specific approach for using a vibratory and auditory stimulation program helps improve brain function and sleep amount and quality in patients with insomnia, according to a study published in the journal Sleep Disorders.

Using fMRI scans, the study found improvements in the functional connectivity in the brain as well as in measured amount of minutes slept and self-reported sleep quality. The areas of the brain that were affected were a combination of areas that are involved in sleep itself as well as areas that have improved function as the result of having better sleep. Such an approach might be particularly useful for people with insomnia by helping them to improve their amount and quality of sleep. The study was performed by the Department of Integrative Medicine and Nutritional Sciences, as well as the Departments of Neurology and Radiology, at Thomas Jefferson University.

Approaches that use a combination of vibratory and auditory stimulation have the goal of matching the brain’s natural rhythms and help improve the amount and quality of sleep. Another goal is to help improve the brain areas affected by a lack of sleep. The current study found changes in areas of the brain associated with both auditory and vibratory sensation. In addition, areas such as the thalamus and prefrontal cortex, which are critical for memory and cognition, were also affected. The current study tested this by tracking changes in functional connectivity using resting state fMRI.

“This study is essential for understanding how vibratory and auditory stimulation can improve sleep amount and sleep quality in insomnia patients,” says senior author on the paper Daniel Monti, MD, chairman of the Department of Integrative Medicine and Nutritional Sciences and Director of the Marcus Institute of Integrative Health at Thomas Jefferson University, in a release. “The study shows how the intervention has a direct effect on vibratory and auditory processing areas of the brain, as well as on important cognitive areas that are impaired when people don’t get enough sleep,”

This study evaluated 30 patients with insomnia symptoms who continued their current treatments and were placed into two groups—the first group received the auditory and vibratory stimulation for approximately one month; and the second group, the control patients, received only their standard-of-care treatment for insomnia for the same time period. Those patients in the active group were given an auditory stimulation program, lasting approximately 60 minutes that they used each night as they went to sleep. In addition, they came into the Marcus Institute of Integrative Health twice a week to receive a combination of vibratory and auditory stimulation for 24 minutes using a specially designed chair that merges the two stimuli. This combination of the vibration and auditory stimulation during the day, coupled with the auditory stimulation during sleep, is supposed to help the brain enter the sleep state more effectively.

Patients underwent brain scanning using resting state fMRI to measure functional connectivity that evaluates how different parts of the brain interact with each other at the start of the study and after a month. Changes in brain connectivity reveal how the brain rewires itself when people are sleeping better. Some of the changes are related to the effects of the therapy itself—the impact of vibration on sensory areas of the brain – and some are related to the effects of improved sleep. This fMRI scan was used to determine the changes in brain function associated with auditory and vibratory stimulation in patients with insomnia. Patients also were evaluated clinically using several different measures of sleep quality and quality of life.

Compared to controls, the patients receiving the auditory and vibratory stimulation had significant changes in functional connectivity in the sensory and auditory receptive areas of the brain—showing how the stimulation seemed to be having its effect. In addition, areas involved in higher cognitive and executive functions, such as the thalamus and prefrontal cortex, were significantly affected—showing that improved sleep improves your brain’s function.

“This is an exciting study that shows how vibration and sound stimulation affect the brain and improve sleep in patients with insomnia and could have important implications for better managing patients with sleep problems,” says corresponding author and neuro-imaging expert Andrew Newberg, MD, professor and director of research at the Department of Integrative Medicine and Nutritional Sciences. The investigators hope that this research will open up new avenues of treatment for insomnia patients.

There are no conflicts of interest. The study was funded by a gift from the Marcus Foundation.