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

NCT06115018 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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.

BEHAVIORAL

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.

COMBINATION_PRODUCT

Palatal surgery combined oropharyngeal rehabilitation

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

Sponsors & Collaborators

  • Yi-Ju, Lai

    lead OTHER

Principal Investigators

  • Yi-Ju Lai, PhD · National Cheng Kung University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06115018 on ClinicalTrials.gov