A Study of Myofunctional Therapy After Sleep Apnea Surgery (MFT-OSA)

Taipei Medical University

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: myofunctional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07231224

W114YSR-03 (Other Identifier)

TMUJIRB No.201912067

TMU113-AE1-B04 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20-65 years
• Moderate-to-severe Obstructive Sleep Apnea (AHI ≥ 15 events/hour) confirmed by PSG
• Friedman palate position grade I-II and tonsil size grade III-IV
• Patients who refuse or are unable to tolerate CPAP

Exclusion criteria

• - Central or mixed sleep apnea
• BMI > 27 kg/m²
• Severe cardiopulmonary disease or psychiatric illness
• Pregnancy or cancer
• Significant weight gain during the follow-up period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

OP+MFT Group

Experimental group

Description:

Participants in this group underwent surgery and began a structured 12-week postoperative myofunctional therapy (MFT) program starting at the third postoperative week.

Treatment:

Procedure: myofunctional therapy

OP-only Group

No Intervention group

Description:

Participants in this group underwent the same surgical procedure but received only routine postoperative follow-up without any additional MFT training.