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NCT Number: NCT06103630

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location status: Recruiting

Location contact

Ching-Hsia Hung, PhD

CONTACT

[email protected]

06-2353535 ext. 5939

About this study

Background:

Obstructive Sleep Apnea (OSA) refers to recurrent upper airway blockages during sleep, leading to symptoms like snoring, 2 interrupted breathing causing micro-awakenings, daytime sleepiness, impaired concentration, and various chronic conditions. The Mandibular Advancement Device (MAD) is a treatment method for OSA, suitable for mild to moderate cases and CPAP noncompliance. However, clinical use of MAD sometimes falls short in comprehensively alleviating the clinical symptoms of obstructive sleep apnea. Therefore, 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. This training aims to increase overall respiratory tract rigidity and improve muscle responsiveness during reduced blood oxygen levels.

Given that some patients do not achieve the expected outcomes after MAD therapy, whether oropharyngeal muscle training can enhance treatment effects becomes a research focus. Thus, this study aims to apply oropharyngeal muscle training to patients who have not achieved the anticipated results following MAD treatment. 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.

Methods:

Fifty diagnosed OSA patients using MAD and consenting to participate are recruited. Patients agreeing to undergo 12 weeks of oropharyngeal muscle training form the treatment group, while those not agreeing form the control group. The treatment group undergoes 12 weeks of training, with weekly in-person follow-ups for treatment intensity adjustment and home-based sessions (30 mins, 1-3 times/day, 3-5 days/week) for a total of 12 weeks. The control group continues MAD therapy. Both groups undergo evaluations of muscle strength and endurance, various sleep physiological tests, ultrasonographic imaging of the tongue and oropharynx, and sleep questionnaire tests before and after the 12- week training period.

Expected Outcomes:

  • Oropharyngeal muscle training may increase muscle strength and endurance.
  • Oropharyngeal muscle training may reduce the severity of sleep-related breathing interruptions.
  • Oropharyngeal muscle training may decrease clinical symptoms.
  • Oropharyngeal muscle training may improve tongue morphology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • Body Mass Index (BMI) ≧ 35
  • Pregnancy
  • Severe obstructive or restrictive lung disease
  • Exercise with high-risk cardiovascular disease
  • History of central or peripheral neurological disease resulting in an inability to perform exercise prescriptions
  • Musculoskeletal or psychological disorders that prevent the performance of exercise prescriptions
  • Chronic illnesses that are ongoing or not yet controlled

Treatment and study plan

Oropharyngeal Exercises

Other

Oropharyngeal Exercises

Mandibular advancement device

Other

Mandibular advancement device

Primary outcomes

  1. Apnea-hypopnea -index

    Time frame: Baseline to 12 weeks

    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).

Secondary outcomes

  1. Tongue muscle strength

    Time frame: Baseline to 12 weeks

    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)

  2. Jaw strength

    Time frame: Baseline to 12 weeks

    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.

  3. Tongue muscle endurance

    Time frame: Baseline to 12 weeks

    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).

  4. Tongue Muscle Thickness

    Time frame: Baseline to 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Hsia Hung, PhD

CONTACT

[email protected]

+886-6-2353535 ext. 5939

Man-Hui Chooi, MS

CONTACT

[email protected]

+886-9-23127284

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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