Study Stopped
Funding issues
Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedMay 24, 2022
May 1, 2022
5 months
August 8, 2019
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea Hypopnea Index (AHI)
Apnea Hypopnea Index during sleep
8-12 weeks
Study Arms (2)
Use of musical instrument
EXPERIMENTALUse of sham musical instrument
SHAM COMPARATORInterventions
exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
Eligibility Criteria
You may qualify if:
- Age 21 to 50
- Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
- Body mass index \< 30 kg/m2
- Mild to moderate OSA, AHI of 5-30
You may not qualify if:
- Apnea hypopnea index on overnight sleep study \> 30 per hour
- Currently practices didgeridoo
- Consumes more than 2 alcoholic beverages per day
- History of chronic lung disease (e.g., COPD, asthma)
- Oral maxillofacial issue or craniofacial musculoskeletal conditions
- Any treatment for OSA (current or past)
- Mobile device use frequency \< once per week
- Homelessness
- No reliable transportation to assessment sessions
- Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
- Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
- Uncorrected low vision or blindness
- Deafness
- No Internet connection/Chrome browser/mobile devices with iOS and Android
- No USB port in computer
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Asate LLC, DEcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Will not be known if participant is getting the actual device or using the placebo
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Chief/Medical Director
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 12, 2019
Study Start
May 1, 2021
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share