SleepFlexTM Treatment of Obstructive Sleep Apnea

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SleepFlex Treatment	SleepFlex	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events	12 weeks	Number of participants with absence of serious adverse events related to the SleepFlex system.
Change in the Apnea-hypopnea Index (AHI)	12 weeks	Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by \>=80% reduction in airflow for \>= 10 seconds in the presence of respiratory effort. Hypopneas are defined by \>=50% reduction in airflow with oxygen desaturation of \>=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia	12 weeks	Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study.