Skip to content

A Study of Myofunctional Therapy After Sleep Apnea Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07231224
Acronym
MFT-OSA
Enrollment
51
Registered
2025-11-17
Start date
2020-01-01
Completion date
2024-01-01
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

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

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.

Interventions

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.

Sponsors

Taipei Medical University
CollaboratorOTHER
National Yang Ming Chiao Tung University Hospital
CollaboratorOTHER
National Tsing Hua University,Taiwan
CollaboratorOTHER
Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

None (Open Label)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Apnea-Hypopnea IndexBaseline, 3 months post-surgery, and 12 months post-surgeryChange 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

MeasureTime frameDescription
Change in Lowest Oxygen Saturation (LSaO₂)Baseline, 3 months post-surgery, and 12 months post-surgeryChange in the lowest oxygen saturation (LSaO₂) during sleep, measured by polysomnography as a percentage
Change in Snore IndexBaseline, 3 months post-surgery, and 12 months post-surgeryChange in the snore index, measured by polysomnography as the percentage of total sleep time with snoring events

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026