Clinical trial NCT04726514: SleepFlexTM Treatment of Obstructive Sleep Apnea
Official title: SleepFlexTM Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Berendo Scientific, LLC
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
timeFrame: 12 weeks
measure: Change in the Apnea-hypopnea Index (AHI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia
timeFrame: 12 weeks
Other outcomes:
measure: Change in Supine AHI
timeFrame: 12 weeks
measure: Change in Non-supine AHI
timeFrame: 12 weeks
Locations:
city: Los Angeles
country: United States
facility: Tower Sleep Medicine
state: California
Study officials:
References: