Back to resultsSleepFlexTM Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SleepFlex
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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
Sites / Locations
- Tower Sleep Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SleepFlex Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04726514
First Posted
January 23, 2021
Last Updated
June 15, 2023
Sponsor
Berendo Scientific, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04726514
Brief Title
SleepFlexTM Treatment of Obstructive Sleep Apnea
Official Title
SleepFlexTM Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berendo Scientific, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SleepFlex Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SleepFlex
Intervention Description
SleepFlex Program
Primary Outcome Measure Information:
Title
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
Description
Number of participants with absence of serious adverse events related to the SleepFlex system.
Time Frame
12 weeks
Title
Change in the Apnea-hypopnea Index (AHI)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia
Description
Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Supine AHI
Description
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.
Time Frame
12 weeks
Title
Change in Non-supine AHI
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tower Sleep Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SleepFlexTM Treatment of Obstructive Sleep Apnea
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