Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID06103630

Efficacy of Oropharyngeal Exercises for Patients With Residual Obstructive Sleep Apnea Using Mandibular Advancement Device

Led by National Cheng-Kung University Hospital · Updated on 2024-03-21

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Obstructive Sleep Apnea (OSA) is a condition where the upper airway repeatedly blocks during sleep, causing symptoms such as snoring, interrupted breathing, daytime sleepiness, and concentration problems. This research evaluates oropharyngeal muscle training as an additional treatment for patients with residual OSA who use a Mandibular Advancement Device (MAD) but have not achieved expected symptom relief. The study aims to assess changes in muscle strength, tongue shape seen by ultrasound, severity of sleep interruptions, and related symptoms. Participants diagnosed with OSA who use MAD will be divided into two groups: one receiving 12 weeks of oropharyngeal muscle training combined with MAD, and a control group continuing MAD alone. The training involves weekly visits to adjust intensity and home exercises lasting 30 minutes, 1 to 3 times daily, 3 to 5 days per week for 12 weeks. Both groups will have assessments before and after this period. During the study, participants will undergo tests measuring tongue and jaw muscle strength and endurance, ultrasound imaging of the tongue and throat, sleep physiological tests, and sleep-related questionnaires. The primary outcome is the apnea-hypopnea index measured from baseline to 12 weeks. Secondary outcomes include changes in tongue muscle strength, jaw strength, endurance, and tongue thickness. The total study duration for each participant is 12 weeks with regular follow-up visits.

CONDITIONS

Brief Title

Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with obstructive sleep apnea (OSA)
  • Aged over 20 years
  • Currently using a Mandibular Advancement Device (MAD) set at least 50% of the maximum achievable amount
Not Eligible

You will not qualify if you...

  • Body Mass Index (BMI) of 35 or higher
  • Pregnancy
  • Severe obstructive or restrictive lung disease
  • High-risk cardiovascular disease preventing exercise
  • History of central or peripheral neurological disease preventing exercise
  • Musculoskeletal or psychological disorders preventing exercise
  • Uncontrolled or ongoing chronic illnesses

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants in the intervention group undergo oropharyngeal muscle training alongside mandibular advancement device therapy, with weekly in-person visits for treatment adjustment and home-based exercises. Participants in the control group continue using the mandibular advancement device without additional exercises.

1 to 2 visits per week (in-person) plus home-based exercises 3 to 5 days per week

Trial Site Locations

Total: 1 location

1

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Actively Recruiting

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Research Team

M

Man-Hui Chooi, MS

C

Ching-Hsia Hung, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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