Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

May 17, 2022 updated by: Clete A. Kushida, Stanford University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Apnea hypopnea index on overnight sleep study > 30 per hour
  2. Currently practices didgeridoo
  3. Consumes more than 2 alcoholic beverages per day
  4. History of chronic lung disease (e.g., COPD, asthma)
  5. Oral maxillofacial issue or craniofacial musculoskeletal conditions
  6. Any treatment for OSA (current or past)
  7. Mobile device use frequency < once per week
  8. Homelessness
  9. No reliable transportation to assessment sessions
  10. Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
  11. Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
  12. Uncorrected low vision or blindness
  13. Deafness
  14. No Internet connection/Chrome browser/mobile devices with iOS and Android
  15. No USB port in computer
  16. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of musical instrument
Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
Sham Comparator: Use of sham musical instrument
Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI)
Time Frame: 8-12 weeks
Apnea Hypopnea Index during sleep
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Asate LLC, DE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-46406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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