Status:
COMPLETED
SleepFlexTM Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Berendo Scientific, LLC
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04726514
Start Date
July 20 2021
End Date
May 31 2022
Last Update
June 22 2023
Active Locations (1)
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1
Tower Sleep Medicine
Los Angeles, California, United States, 90048