National Cheng Kung University Hospital
Tainan, 704, Taiwan
Location status: Recruiting
NCT Number: NCT06103630
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Tainan, 704, Taiwan
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oropharyngeal Exercises
Mandibular advancement device
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).
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)
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.
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).
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.
Contact information is provided by the study sponsor or research team.
National Cheng-Kung University Hospital
Other
Efficacy of Oropharyngeal Exercises for Patients With Residual Obstructive Sleep Apnea Using Mandibular Advancement Device
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