SleepFlexTM Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

SleepFlexTM Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726514
• Other study ID #: 0100
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2023
• Source: Berendo Scientific, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• SleepFlex
SleepFlex Program

Locations

Country	Name	City	State
United States	Tower Sleep Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Berendo Scientific, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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