Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed and dated a consent form agreeing to take part
• People who are unable to tolerate or have chosen not to use a CPAP or similar breathing pressure machine for sleep apnea
• People who do not have very large tonsils (rated 3 or 4 out of 4 on a standard sizing scale)
• People who can stick their tongue out at least 20mm past their upper front teeth
• People who have no uncontrolled blockage in their nose and are able to breathe through their nose
• People whose medications have been stable for at least one month
• People who are willing and available to follow all study procedures for the full duration of the trial
• People who are male or female, of any race, aged 18 to 70 years
• People diagnosed with mild to moderate or moderate to severe obstructive sleep apnea (OSA), with a sleep apnea score — called an AHI — greater than 5 and less than 30 per hour, and without serious complications such as central sleep apnea, breathing muscle weakness, history of stroke, or long-term opioid use
• People without significant other sleep disorders that would need separate evaluation or interfere with at-home sleep testing (such as severe insomnia or movement disorders during sleep)
• People with a body mass index (BMI) below 35 kg/m²
• People with a neck measurement smaller than 45 cm
• People whose blood oxygen levels during sleep do not drop severely (average nighttime oxygen level above 82%)
• People whose jaw can move forward more than 5mm
• People with teeth and gums assessed as adequate by the trial's dentist
• People who own a smartphone capable of downloading a specific oxygen monitoring app (the O2 Ring app)

Who may not be able to join:

• People who cannot comfortably breathe through their nose
• People where more than 25% of their sleep apnea events are of the central type (caused by the brain rather than a blocked airway)
• People with severe OSA where the AHI score is above 40 per hour
• People with an uncontrolled sleep disorder such as narcolepsy, chronic insomnia, restless legs syndrome, or REM sleep behavior disorder
• People whose sleep apnea occurs mainly when lying on their back, with more than twice as many breathing events in that position compared to other positions
• People who have previously had surgery to change the structure of their airway to treat sleep apnea, such as removal of throat tissue (UPPP), jaw advancement surgery, or tongue or hyoid bone suspension
• People who have had surgery to restore normal anatomy — such as tonsil removal, adenoid removal, nasal septum correction, or nasal polyp removal — within the past 6 months
• People who have a nerve stimulation device implanted under the tongue (hypoglossal nerve stimulator)
• People who have used a CPAP machine or a dental sleep device within two weeks before the screening sleep test
• People who expect to have a medical treatment during the study that could change their sleep apnea severity, such as weight loss surgery or airway surgery
• People with loose teeth or serious gum disease
• People who have had a tooth removed or a dental implant placed within the past 12 months
• People who wear removable dentures
• People with a history of jaw joint problems (temporomandibular joint disorder, also known as TMJ)
• People with blood pressure that remains poorly controlled despite taking three or more blood pressure medications
• People with severe heart failure, ongoing atrial fibrillation, or a recent heart attack or acute coronary event in the past 30 days
• People with neuromuscular diseases such as myasthenia gravis, ALS, Guillain-Barré syndrome, or muscular dystrophy, or conditions that cause shallow breathing during sleep or bluish discoloration of the fingers or toes
• People with serious lung disease that causes significant drops in oxygen levels, such as severe COPD, interstitial lung disease, or pulmonary hypertension
• People who have had a stroke or similar brain blood vessel event within the past 12 months
• People who use a pacemaker or another life-supporting device
• People who expect their body weight to change by more than 5% during the study period
• People already taking part in another study that could interfere with this trial

Important: Always verify eligibility with the trial site directly before applying.