The Efficacy and Maintain Effect of OPR on OSA Patients After Palatal Surgery

NCT ID: NCT06115018

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to evaluate the maintain effect of palatal surgery and oropharyngeal rehabilitation (OPR) by using the severity of obstructive sleep apnea (OSA), tongue muscle strength and the space of the upper airway in patients with OSA.The main questions it aims to answer are:

1. Will the severity of OSA, tongue muscle strength and the space of upper airway improve more in the palatal surgery combined OPR group than the other two groups?

2. Will The maintain effect of tongue muscle strength and the space of upper airway be better in the palatal surgery combined OPR group? Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness.The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months.

Detailed Description

Background: The pathophysiology of obstructive sleep apnea (OSA) includes anatomical and non-anatomical factors. The patients who are suitable for sleep surgery may have the non-anatomical factors at the same time. Oropharyngeal rehabilitation (OPR) for the extrinsic and intrinsic muscles of the tongue might mitigate sleep apnea by preventing airway collapse and reducing the volume of the tongue base. In addition, previous studies also suggested that increasing the tension of the tongue extrinsic/intrinsic muscles may decrease the collapsibility of the upper airway and further prevent airway collapse during sleep. Although palatal surgery and OPR both can improve the severity of OSA, there is lack of literatures about the maintain effect of palatal surgery combined OPR. The aim of this study is to evaluate the maintain effect by using the severity of OSA, tongue muscle strength and the space of the upper airway. Our team have developed force sensing resistor to record the times and frequency of OPR at home from 2022. However, the investigators have to use SD card to record data in the present version. The investigators will optimize the force sensing resistor to upload data to Google Drive by using wifi. In this way, the investigators will know the daily training situation and give feedback to participants immediately by using LINE.

Methods：Seventy-five adult OSA patients will be recruited for this study. Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness. In the palatal surgery combined OPR group, the participants will receive the palatal surgery and 3-month OPR. In the palatal surgery group and OPR group, the participants will receive palatal surgery or 3-month OPR, respectively. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.

Expected outcomes：

1. The severity of OSA, tongue muscle strength and the space of upper airway will improve more in the palatal surgery combined OPR group than the other two groups.

2. The maintain effect of tongue muscle strength and the space of upper airway is better in the palatal surgery combined OPR group.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palatal surgery group

In the palatal surgery group, the participants will receive palatal surgery.To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.

Group Type: ACTIVE_COMPARATOR

Palatal surgery

Intervention Type: PROCEDURE

Palate surgery has evolved from the ablative partial palate resections, which favored the removal of the soft tissue that obstructed the upper airway (UA), to more recent innovative reconstructive procedures that not only address the level of palatal obstruction, but the type of palatal or lateral pharyngeal wall collapse.

Oropharyngeal rehabilitation group

In the oropharyngeal rehabilitation (OPR) group, the participants will receive 12-week OPR. The OPR for the OPR group included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.

Group Type: ACTIVE_COMPARATOR

Oropharyngeal rehabilitation

Intervention Type: BEHAVIORAL

Oropharyngeal rehabilitation (OPR) focus on the upper airway muscle including tongue muscle, palatal muscles and paryngeal muscles. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress.

Palatal surgery combined OPR group

In the palatal surgery combined OPR group, the participants will receive palatal surgery, then 12-week OPR. The program of OPR for this group is as the same of OPR group.

Group Type: EXPERIMENTAL

Palatal surgery combined oropharyngeal rehabilitation

Intervention Type: COMBINATION_PRODUCT

Participants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above.

Interventions

Palatal surgery

Palate surgery has evolved from the ablative partial palate resections, which favored the removal of the soft tissue that obstructed the upper airway (UA), to more recent innovative reconstructive procedures that not only address the level of palatal obstruction, but the type of palatal or lateral pharyngeal wall collapse.

Intervention Type: PROCEDURE

Oropharyngeal rehabilitation

Oropharyngeal rehabilitation (OPR) focus on the upper airway muscle including tongue muscle, palatal muscles and paryngeal muscles. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress.

Intervention Type: BEHAVIORAL

Palatal surgery combined oropharyngeal rehabilitation

Participants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• mild to severe obstructive sleep apnea patients

Exclusion Criteria

• Chronic rhinosinusitis with nasal polyps
• Adenoidal hypertrophy
• Bilateral tonsile hypertrophy
• Morbid Obesity
• Drug or alcohol abuse in one year
• Pregnancy
• Severe lung disease
• Heart disease with high risk of exercise
• Neuromuscular disease that can't follow the exercise program
• Central or mixed sleep apnea

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi-Ju, Lai

OTHER

Sponsor Role: lead

Responsible Party

Yi-Ju, Lai

Institute of Physical Education, Health and Leisure Studies, College of Management, National Cheng Kung University, Tainan, Taiwan

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi-Ju Lai, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Ju Lai, PhD

Role: CONTACT

11208035@gs.ncku.edu.tw

+886-6-2353535 ext. 4063

Facility Contacts

Yi-Ju Lai, PhD

Role: primary

11208035@gs.ncku.edu.tw

+886-6-2353535 ext. 4063

Other Identifiers

B-BR-112-052

Identifier Type: -

Identifier Source: org_study_id