Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

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Use of musical instrument

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Use of sham musical instrument

Group Type SHAM_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No