Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Sleep Apnea Clinical Trial

Official title:

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04053153
• Other study ID #: IRB-46406
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Asate LLC, DE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)	Apnea Hypopnea Index during sleep	8-12 weeks