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OpenTrials
Completed

NCT Number: NCT04726514

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

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tower Sleep Medicine

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SleepFlex

Device

SleepFlex Program

Primary outcomes

  1. Number of Participants With Freedom From SleepFlex-related Serious Adverse Events

    Time frame: 12 weeks

    Number of participants with absence of serious adverse events related to the SleepFlex system.

  2. Change in the Apnea-hypopnea Index (AHI)

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 12 weeks

    Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study.

Other outcomes

  1. Change in Supine AHI

    Time frame: 12 weeks

    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.

  2. Change in Non-supine AHI

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Berendo Scientific, LLC

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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