Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Study Overview
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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.

Official Title
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Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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