A Study of Myofunctional Therapy After Sleep Apnea Surgery

NCT07231224 | Completed

• 3 other identifiers: TMUJIRB No.201912067W114YSR-03TMU113-AE1-B04
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; Myofunctional therapy (MFT); Upper airway surgery; Oropharyngeal exercises; Postoperative outcomes; Polysomnography (PSG); Apnea-Hypopnea Index (AHI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Lowest Oxygen Saturation (LSaO₂)

  Baseline, 3 months post-surgery, and 12 months post-surgery

• Change in Snore Index

  Baseline, 3 months post-surgery, and 12 months post-surgery

Study Arms (2)

OP+MFT Group

EXPERIMENTAL

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

OP-only Group

NO INTERVENTION

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

Interventions

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.

OP+MFT Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead
• Taipei Medical University: collaborator
• National Yang Ming Chiao Tung University Hospital: collaborator
• National Tsing Hua University,Taiwan: collaborator

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital

New Taipei, Taiwan, 235, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• CHENGJUNG WU, MD

  Shuang Ho Hospital, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients were divided into two parallel groups based on personal willingness after discussion: Group A (OP+MFT) or Group B (OP-only)

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following the publication of the primary manuscript
• 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.

Locations

TW (1)