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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: myofunctional therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • New Taipei, Taiwan, Taiwan, 235
      • Taipei Medical University - Shuang Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OP+MFT Group; Participants in this group underwent surgery and began a structured 12-week postoperative myofunctional therapy (MFT) program starting at the third postoperative week.	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.
No Intervention: OP-only Group; Participants in this group underwent the same surgical procedure but received only routine postoperative follow-up without any additional MFT training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apnea-Hypopnea Index	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.	Baseline, 3 months post-surgery, and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lowest Oxygen Saturation (LSaO₂)	Change in the lowest oxygen saturation (LSaO₂) during sleep, measured by polysomnography as a percentage	Baseline, 3 months post-surgery, and 12 months post-surgery
Change in Snore Index	Change in the snore index, measured by polysomnography as the percentage of total sleep time with snoring events	Baseline, 3 months post-surgery, and 12 months post-surgery

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Collaborators: Taipei Medical University; National Yang Ming Chiao Tung University Hospital; National Tsing Hua University,Taiwan
• Investigators: Principal Investigator: CHENGJUNG WU, MD, Shuang Ho Hospital, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Oropharyngeal exercises; Polysomnography (PSG); Apnea-Hypopnea Index (AHI); Postoperative outcomes; Upper airway surgery; Myofunctional therapy (MFT)
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Dentistry; Myofunctional Therapy
• Other Study ID Numbers: TMUJIRB No.201912067; W114YSR-03 (Other Identifier: Taipei Medical University Shuang Ho Hospital Young Scholar Research Grant); TMU113-AE1-B04 (Other Identifier: Taipei Medical University Newly Recruited Faculty Research Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data presented in this study are available on reasonable request from the corresponding author
• IPD Sharing Time Frame: Data will be available following the publication of the primary manuscript
• IPD Sharing Access Criteria: Data access can be granted upon reasonable request to the corresponding author. Requesters may need to provide a study protocol or analysis plan to ensure the responsible use of the de-identified data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No