Back to results

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Primary Purpose

Sleep Apnea

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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
Pregnancy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Use of musical instrument

Use of sham musical instrument

Arm Description

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI)

Apnea Hypopnea Index during sleep

Secondary Outcome Measures

Full Information

NCT ID

NCT04053153

First Posted

August 8, 2019

Last Updated

May 17, 2022

Sponsor

Stanford University

Collaborators

Asate LLC, DE

1. Study Identification

Unique Protocol Identification Number

NCT04053153

Brief Title

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Official Title

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Funding issues

Study Start Date

May 1, 2021 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Asate LLC, DE

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Will not be known if participant is getting the actual device or using the placebo

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Use of musical instrument

Arm Type

Experimental

Arm Title

Use of sham musical instrument

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Intervention Description

exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Primary Outcome Measure Information:

Title

Apnea Hypopnea Index (AHI)

Description

Apnea Hypopnea Index during sleep

Time Frame

8-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 Pregnancy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

We'll reach out to this number within 24 hrs