SleepFlexTM Treatment of Obstructive Sleep Apnea

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: SleepFlex

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Tower Sleep Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SleepFlex Treatment	Device: SleepFlex; SleepFlex Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events	Number of participants with absence of serious adverse events related to the SleepFlex system.	12 weeks
Change in the Apnea-hypopnea Index (AHI)	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.	12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Supine AHI	Change in the supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The supine position is defined by sleeping on one's back.	12 weeks
Change in Non-supine AHI	Change in the non-supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The non-supine position is defined by sleeping in body positions other than one's back. Body position information is collected by the home sleep apnea test, and position-specific information is calculated.	12 weeks

Collaborators and Investigators

• Sponsor: Berendo Scientific, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No