SleepFlexTM Treatment of Obstructive Sleep Apnea

NCT ID: NCT04726514

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2022-05-31

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

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SleepFlex Treatment

Group Type: EXPERIMENTAL

SleepFlex

Intervention Type: DEVICE

SleepFlex Program

Interventions

SleepFlex

SleepFlex Program

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berendo Scientific, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tower Sleep Medicine

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0100

Identifier Type: -

Identifier Source: org_study_id