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

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05717959
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea of Adult	Behavioral: Oropharyngeal Exercises	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
• Actual Study Start Date: Sep 2, 2022
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group We conducted a once a week, 12-week-intervention of Oropharyngeal Exercises and Mandibular advancement device	Behavioral: Oropharyngeal Exercises; Oropharyngeal Exercises
Sham Comparator: control group Mandibular advancement device	Behavioral: Oropharyngeal Exercises; Oropharyngeal Exercises

Outcome Measures

Primary Outcome Measures

1. Apnea-hypopnea -index [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 Outcome Measures

1. Tongue muscle strength [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. Tongue muscle endurance [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

• National Cheng-Kung University Hospital

Investigators

• Principal Investigator: Ching Hsia Hung, PhD, National Cheng Kung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT05717959
• Other Study ID Numbers: B-ER-111-222
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Cheng-Kung University Hospital: Obstructive Sleep Apnea; Mandibular advancement device; oropharyngeal exercises
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Feb 8, 2023