Clinical trial NCT05717959: Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Official title: Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Obstructive Sleep Apnea
Mandibular advancement device
oropharyngeal exercises
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combined treatment with MAD and OE for adult patients with obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea.

Detailed description: Background: Obstructive Sleep Apnea (OSA) is a sleeping disorder with recurrent upper airway obstruction during sleep. Patients with OSA often suffer from daytime sleepiness, snoring, and interrupted breathing during sleep. The etiology of OSA can divide into anatomical causes, including narrow, crowded, or easily collapsible upper airway, and non-anatomical causes, including low respiratory arousal threshold, ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control. A mandibular advancement device (MAD) is one of the treatment options for mild to moderate OSA patients. Oropharyngeal exercises (OE) are a novel intervention targeted at internal/external tongue muscle training with significant improvements in the muscle tension and severity of OSA. The efficacy of combined treatment with MAD and OE has not been investigated. Thus, the present study aims to determine the effectiveness of combing MAD and OE by assessing the tongue function and severity of OSA in patients with OSA.

Methods: A total of 20 participants using MAD for OSA were included in the study. Participants will be divided into two groups: the treatment group with the 12-week OE. OE consists of one to three times 30-minute sessions per day, 3 to 5 days per week for 12 weeks. The weekly clinic visits are required to adjust the intensity of the home exercise program and monitor the training progress. The participants in two groups will receive polysomnography (PSG) test, tongue muscle strength, and endurance testing, at baseline and after the intervention.

Expected results: Combined treatment with MAD and OE for adult patients with mild to moderate obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea

Eligibility criteria: Inclusion Criteria:

* OSA patients
* aged over 20 years old
* wearing a MAD

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

Primary outcomes:
measure: Apnea-hypopnea -index
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Tongue muscle strength
timeFrame: Baseline to 12 weeks
measure: Tongue muscle endurance
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Ching Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: