Clinical Trials Directory

Trials / Completed

CompletedNCT07231224

A Study of Myofunctional Therapy After Sleep Apnea Surgery

Postoperative Myofunctional Therapy Enhances Surgical Outcomes in Patients With Obstructive Sleep Apnea: A Prospective Comparative Stud

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Taipei Medical University Shuang Ho Hospital · Academic / Other
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent upper airway collapse. While surgery is a common treatment, its success rates are variable. Myofunctional therapy (MFT), a program of targeted oropharyngeal exercises, has emerged as a promising adjunctive treatment to improve surgical outcomes. This study prospectively compared outcomes in adult patients with moderate-to-severe OSA who received postoperative MFT (OP+MFT) versus those who underwent surgery alone (OP). Following surgery, patients were allocated to either the OP+MFT group, which began a 12-week MFT program, or the OP-only group. Polysomnography (PSG) was performed at baseline and at 3 and 12 months post-surgery. The study found that the OP+MFT group showed significantly greater improvements in key sleep parameters, including the Apnea-Hypopnea Index (AHI) and lowest oxygen saturation, compared to the OP group. These benefits were most pronounced at the 3-month follow-up, supporting the conclusion that postoperative MFT is a safe and effective adjunct to surgery for OSA.

Detailed description

Obstructive Sleep Apnea (OSA) is a prevalent condition associated with significant morbidity, including hypertension and cardiovascular disease. The first-line treatment, Continuous Positive Airway Pressure (CPAP), is limited by poor long-term patient adherence, with compliance rates often below 20%. For patients who are intolerant to CPAP, surgical options are available, but their long-term success rates are modest, averaging around 30%. This study is based on the rationale that surgery primarily addresses static anatomical obstructions, while a key functional deficit-poor neuromuscular tone of the upper airway dilator muscles-remains uncorrected by surgery alone. Myofunctional therapy (MFT) is a structured exercise program designed to strengthen oropharyngeal muscles (e.g., tongue, soft palate), improve neuromuscular control, and enhance airway stability during sleep. This study was designed to evaluate the synergistic effect of combining surgery with postoperative MFT. The hypothesis is that a dual approach, where surgery provides anatomical relief and MFT enhances dynamic airway stability, will lead to superior treatment outcomes compared to surgery alone.

Conditions

Interventions

TypeNameDescription
PROCEDUREmyofunctional therapyA 12-week structured program of oropharyngeal exercises that commenced three weeks after surgery. The program consisted of initial face-to-face instruction, twice-daily home practice (15 minutes each) guided by videos, and biweekly supervision. Exercises included tongue elevation and protrusion drills, soft palate elevation, and pharyngeal wall contractions to enhance neuromuscular control of the upper airway.

Timeline

Start date
2020-01-01
Primary completion
2024-01-01
Completion
2024-01-01
First posted
2025-11-17
Last updated
2025-11-17

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT07231224. Inclusion in this directory is not an endorsement.