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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | myofunctional therapy | A 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.