Impact of Muscle Training Device on Non-Severe OSA

NCT06910930 | Recruiting

• 1 other identifier: MTU-EC-IM-0-293/67
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test for the efficacy of the newly invented device #DidgeriTU with non-severe obstructive sleep apnea. The main question it aims to answer is:

• Can DidgeriTU reduce apnea events in patients with non-severe obstructive sleep apnea? Researchers will compare DidgeriTU with a sham device to see how the apnea event has changed. Participants will:
• Use DidgeriTU or sham device for 3 month
• Do an online questionnaire once a month during the study
• Home sleep test, lung function test, and tongue strength test at the start and end of the study

Conditions

OSA; Obstructive Sleep Apnea

Keywords

Device; EMST; Powerbreathe; didgeridoo; didgeriTU; Expiratory muscle exercise; reverse CPAP

Outcome Measures

Primary Outcomes (1)

• Change of apnea event after DidgeriTU usage compared with sham device

  Participants with a known history of non-severe obstructive sleep apnea will repeat the home sleep apnea test. The study will include patients with non-severe OSA(Apnea-hypopnea index 5-29/hr) from HSAT. After the usage of DidgeriTU or sham device for 3 months, the participant will repeat HSAT to explore the change of AHI after DidgeriTU use compared with sham device.

  3 months

Secondary Outcomes (7)

• Change of OSA severity after the usage of DidgeriTU comparing with sham device

  3 months

• Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device

  3 months

• Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device

  3 months

• Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device

  3 months

• change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device

  3 months

Study Arms (2)

DidgeriTU

ACTIVE COMPARATOR

patients with non severe OSA using DidgeriTU device

Device: DidgeriTU

sham device

SHAM COMPARATOR

Patients with non severe OSA receive a device that look alike didgeriTU but without resistance plate

Device: Sham device

Interventions

DidgeriTU DEVICE

the study device that immitate the principle of didgeridoo for expiratory muscle exercise

DidgeriTU

Sham device DEVICE

a device that look alike DidgeriTU but without resistance plate

sham device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with mild to moderate obstructive sleep apnea.
• Age 18 years or older.
• Patients voluntarily consent to provide information for research purposes.

You may not qualify if:

• Patients with an average apnea-hypopnea index (AHI) of \<4 or \>29 events per hour after repeated diagnosis using a home sleep apnea test.
• Patients who refused to cease using CPAP during the study process
• Patients with a history of chronic lung disease.
• Elderly patients with neurological conditions that impair cognitive function, such as dementia, stroke, or psychiatric disorders.
• Patients taking medications that may affect muscle function within 3 months before the start of the study.
• Patients with hypothyroidism or other conditions that may affect muscle function.
• Patients who consume alcohol at a moderate level or higher

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University Hospital

Pathum Thani, Thailand

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Naphitchaya Wiriya, Internal medicine

CONTACT

+66870883390; jazhana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Naphitchaya Wiriya, MD.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)