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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng-Kung University Hospital

About this trial

Oropharyngeal muscle training has emerged as a novel adjunctive treatment approach, involving training of the swallowing muscle group and tongue muscles to prevent tongue collapse, reduce tongue base volume during sleep, and strengthen muscle tension.

Therefore, the objective is to assess changes in oropharyngeal muscle strength, ultrasonographic tongue morphology, severity of sleep related breathing interruptions, clinical symptoms, and correlations among these factors. Oropharyngeal muscle training for patients with residual OSA using MAD can significantly 1. increase muscle strength and endurance. 2. reduce the severity of sleep-related breathing interruptions. 3. decrease clinical symptoms. 4. improve tongue morphology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

OSA patients

Aged over 20 years

Wearing MAD (The amount of MAD is at least 50% of the maximum amount that the patient can achieve.)

Disqualifiers

Body Mass Index (BMI) ≧ 35

Pregnancy

Severe obstructive or restrictive lung disease

Exercise with high-risk cardiovascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oropharyngeal Exercises

    Other intervention

    Oropharyngeal Exercises

  • Mandibular advancement device

    Other intervention

    Mandibular advancement device

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Control groupSham comparator 1 intervention
Group B: Intervention groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Apnea-hypopnea -index

Assessed using Polysomnography (PSG). The average apnea and hypopnea events per hour, oxygen saturation index and the snoring index will be obtained during the sleep test(PSG).

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Tongue muscle strength

The maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)

Time frame
Baseline to 12 weeks
2

Jaw strength

Jaw strength will be measured using a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA). The data will be presented in kilogram-weight. The minimum score is 0 and a higher score indicates stronger in jaw strength.

Time frame
Baseline to 12 weeks
3

Tongue muscle endurance

The endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds).

Time frame
Baseline to 12 weeks
4

Tongue Muscle Thickness

Sonography will be performed over the participant's neck region to assess the changes in tongue muscle thickness during normal breathing.

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.