SleepFlexTM Treatment of Obstructive Sleep Apnea

Inclusion Criteria

• Age 21 years and older
• Mild to moderate OSA, defined as AHI >10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment
• Central or mixed disordered breathing events (≤25% of total number of events)
• Unable to tolerate or decline positive airway pressure therapy
• Body mass index ≤32 kg/m2
• Able to protrude tongue ≥20 mm beyond maxillary incisors
• Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification
• No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
• Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score >10
• No uncontrolled nasal obstruction
• Absence of moderate to severe mandibular insufficiency
• No previous surgery involving the oral cavity or pharynx other than tonsillectomy
• No previous radiation therapy to the head and neck
• No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders
• No psychiatric diagnoses other than treated depression or mild anxiety
• Stable medication regimen for ≥1 month
• No acute illness or infection
• Ownership of personal smartphone with iOS or Android operating system
• No known hypersensitivity to any material of the SleepFlex devices

Exclusion Criteria

• Unwilling or unable to provide informed written consent in English
• Pregnancy, breastfeeding, or plans to become pregnant
• Smoker (tobacco or recreational drugs) in the past month
• Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day
• Significant vision or hearing problems
• Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
• Any other reason the investigator determines as being unfit for study participation