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NCT Number: NCT07231224

A Study of Myofunctional Therapy After Sleep Apnea Surgery

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University - Shuang Ho Hospital

New Taipei, Taiwan, 235

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofunctional Therapy

Procedure

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.

Primary outcomes

  1. Change in Apnea-Hypopnea Index

    Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery

    Change in AHI from baseline, measured by polysomnography in events per hour. Treatment success is defined as a reduction of ≥50% from baseline AHI and a final AHI of <20 events/hour.

Secondary outcomes

  1. Change in Lowest Oxygen Saturation (LSaO₂)

    Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery

    Change in the lowest oxygen saturation (LSaO₂) during sleep, measured by polysomnography as a percentage

  2. Change in Snore Index

    Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery

    Change in the snore index, measured by polysomnography as the percentage of total sleep time with snoring events

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Collaborators

  • National Tsing Hua University,Taiwan
  • National Yang Ming Chiao Tung University Hospital
  • Taipei Medical University

Registry information

Official study title

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

Acronym: MFT-OSA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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