Sleep Apnea
Conditions
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.
Interventions
DEVICEExercise equipment (a musical instrument that is based on the Medical Didgeridoo)
exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
Sponsors
Asate LLC, DE
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Will not be known if participant is getting the actual device or using the placebo
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | 8-12 weeks | Apnea Hypopnea Index during sleep |
Outcome results
None listed