SleepFlexTM Treatment of Obstructive Sleep Apnea

NCT04726514 | Completed Results FDA Device

• 1 other identifier: 0100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia

  12 weeks

Other Outcomes (2)

• Change in Supine AHI

  12 weeks

• Change in Non-supine AHI

  12 weeks

Study Arms (1)

SleepFlex Treatment

EXPERIMENTAL

Device: SleepFlex

Interventions

SleepFlex DEVICE

SleepFlex Program

SleepFlex Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Berendo Scientific, LLC: lead

Study Sites (1)

Tower Sleep Medicine

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Eric Kezirian
• Organization: Berendo Scientific, LLC

eric.kezirian@gmail.com

4152358706

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: July 20, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)