A Study of Myofunctional Therapy After Sleep Apnea Surgery

NCT ID: NCT07231224

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-01-01

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.

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

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

myofunctional therapy

Intervention Type: 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-only Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: collaborator

National Yang Ming Chiao Tung University Hospital

OTHER

Sponsor Role: collaborator

National Tsing Hua University,Taiwan

OTHER

Sponsor Role: collaborator

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CHENGJUNG WU, MD

Role: PRINCIPAL_INVESTIGATOR

Shuang Ho Hospital, Taipei Medical University

Locations

Taipei Medical University - Shuang Ho Hospital

New Taipei, Taiwan, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W114YSR-03

Identifier Type: OTHER

Identifier Source: secondary_id

TMU113-AE1-B04

Identifier Type: OTHER

Identifier Source: secondary_id

TMUJIRB No.201912067

Identifier Type: -

Identifier Source: org_study_id