Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obstructive Sleep Apnea

NCT07539870 | Not Yet Recruiting DMC

• 1 other identifier: CEHDF-2740
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the isolated and combined effects of orofacial myofunctional therapy (OMT) and continuous positive airway pressure (CPAP) in adults with mild-to-moderate obstructive sleep apnea. The main questions it aims to answer are whether OMT alone, CPAP alone, or combined OMT plus CPAP improves obstructive sleep apnea severity at Week 12, as measured by the apnea-hypopnea index (AHI), and whether these interventions improve mandibular excursion. Researchers will compare 4 groups-sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, and combined OMT plus CPAP plus standard of care-to assess differences in respiratory and anatomical-functional outcomes. Participants will be randomized to 1 of the 4 study arms. During the 12-week supervised intervention phase, participants will receive their assigned intervention together with standardized sleep-hygiene and lifestyle counseling. Assessments include sleep recording, mandibular excursion measurements, questionnaires on sleepiness and sleep quality, dento-occlusal and anthropometric measurements, and treatment adherence monitoring. After Week 12, participants will enter an observational follow-up phase through Week 52 to evaluate durability of treatment effects, treatment persistence, symptom recurrence, and clinically indicated treatment modifications.

Conditions

Obstructive Sleep Apnea

Keywords

Mild-to-Moderate Obstructive Sleep Apnea; Orofacial Myofunctional Therapy; Continuous Positive Airway Pressure; Apnea-Hypopnea Index; Mandibular Excursion; George Gauge; Jaw Motion Analyser; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  AHI at week 12, adjusted for baseline AHI, assessed by overnight sleep recording and scored according to the prespecified study scoring criteria, expressed in events/hour.

  Week 12

Secondary Outcomes (19)

• Change in Mandibular Excursion

  Baseline and Week 12

• Change in Apnea-Hypopnea Index (AHI) Over Follow-up

  Baseline, Week 12, and Week 52

• Change in Oxygen Desaturation Index (ODI)

  Baseline, Week 12, and Week 52

• Change in Oxygen Saturation Nadir (SpO2 nadir)

  Baseline, Week 12, and Week 52

• Calibration of Type III Polygraphy-Derived AHI Against Type I Polysomnography-Derived AHI

  Week 12

Other Outcomes (3)

• Participants With at Least 1 Treatment-Emergent Adverse Event

  Baseline to Week 52

• Participants Who Discontinued Assigned Treatment Due to Adverse Events or Intolerance

  Baseline to Week 52

• Participants Withdrawn From the Study Due to Adverse Events

  Baseline to Week 52

Study Arms (4)

Sham + Standard of Care.

SHAM COMPARATOR

Participants receive placebo breathing sessions with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations during the 12-week supervised intervention period.

Behavioral: Sham Breathing Sessions; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling

Orofacial Myofunctional Therapy + Standard of Care

EXPERIMENTAL

Participants receive a structured orofacial myofunctional therapy program for 12 weeks, consisting of 3 sessions per day, each lasting approximately 8 minutes, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.

Behavioral: Orofacial Myofunctional Therapy; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling

CPAP + Standard of Care

ACTIVE COMPARATOR

Participants receive continuous positive airway pressure treatment for 12 weeks, with adherence targets of more than 4 hours per night, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.

Device: Continuous Positive Airway Pressure; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling

Orofacial Myofunctional Therapy + CPAP + Standard of Care

EXPERIMENTAL

Participants receive the full orofacial myofunctional therapy program and continuous positive airway pressure concurrently during the 12-week supervised intervention period, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.

Behavioral: Orofacial Myofunctional Therapy; Device: Continuous Positive Airway Pressure; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling

Interventions

Sham Breathing Sessions BEHAVIORAL

Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.

Sham + Standard of Care.

Orofacial Myofunctional Therapy BEHAVIORAL

Structured orofacial myofunctional therapy program delivered over 12 weeks, consisting of 3 sessions per day of approximately 8 minutes each. Participants assigned to OMT will receive a 30-minute training session delivered by a speech therapist, either face-to-face or via videoconference. Training includes exercise demonstration, guided practice, posture correction, and access to PDF handouts and instructional videos. Adherence will be monitored primarily using the Loop Habit Tracker application configured for 3 daily reminders; a paper logbook will be used when digital tracking is not feasible. Reinforcement messages will be sent every 48 hours, and a Day-30 videoconference will be conducted to review technique and troubleshoot barriers.

Orofacial Myofunctional Therapy + CPAP + Standard of Care; Orofacial Myofunctional Therapy + Standard of Care

Continuous Positive Airway Pressure DEVICE

Participants assigned to CPAP will receive a Week-1 telephone call to confirm installation and resolve technical issues, and a Week-6 adherence support visit to optimize mask fit and encourage use. Device-derived adherence metrics will include mean nightly use, P90/P95 pressure, median pressure, and mask leak statistics.

CPAP + Standard of Care; Orofacial Myofunctional Therapy + CPAP + Standard of Care

Standard of Care Sleep-Hygiene and Lifestyle Counseling BEHAVIORAL

Standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations provided uniformly to all participants, including regular sleep-wake schedules, avoidance of alcohol and sedatives before bedtime, reduction of evening screen exposure, optimization of the sleep environment, and encouragement of healthy dietary habits and physical activity aimed at gradual weight control.

CPAP + Standard of Care; Orofacial Myofunctional Therapy + CPAP + Standard of Care; Orofacial Myofunctional Therapy + Standard of Care; Sham + Standard of Care.

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Mild-to-moderate OSA (AHI 5.0-29.9 events/hour) confirmed by Type I polysomnography.
• Protrusive excursion of at least 5 mm measured with the George Gauge.
• No previous treatment with CPAP or OMT.
• Ability to perform oropharyngeal exercises.
• Written informed consent.

You may not qualify if:

• Severe obstructive sleep apnea (AHI 30 events/hour or higher) or urgent need for CPAP
• Suspected or confirmed obesity hypoventilation syndrome, chronic ventilatory failure, or severe obesity associated with daytime hypercapnia or hypoxemia
• Clinically significant insomnia, defined as an Insomnia Severity Index (ISI) score \> 14 at screening.
• Uncontrolled psychiatric or neurological conditions likely to substantially affect sleep quality or daytime symptoms independently of OSA (e.g., major depressive episode, severe anxiety disorder, chronic disabling migraine)., as judged by the investigator.
• Current use of medications likely to affect sleep architecture, respiratory drive, or PAP tolerance, including chronic opioid therapy and other sedative medications judged incompatible with study participation.
• Unstable or severe cardiovascular disease requiring priority standard management, including poorly controlled arrhythmia, nocturnal angina, decompensated heart failure, treatment-resistant hypertension, or recent acute coronary syndrome
• Uncontrolled diabetes mellitus requiring treatment intensification, for example - HbA1c greater than 10% and/or symptomatic hyperglycemia
• Neurological or ear-nose-throat disease affecting the upper airway
• Craniofacial abnormalities
• Maxillofacial surgery within the previous 6 months
• Temporomandibular pain preventing completion of exercises
• Active periodontitis
• Pregnancy
• Foreseeable non-adherence to the intervention
• Inability to use CPAP despite standard fitting and troubleshooting, or any contraindication to CPAP treatment.

Sponsors & Collaborators

• Saint-Joseph University: lead

Related Publications (8)

• Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.

  PMID: 25348130 RESULT

• Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.

  PMID: 19234106 RESULT

• Ieto V, Kayamori F, Montes MI, Hirata RP, Gregorio MG, Alencar AM, Drager LF, Genta PR, Lorenzi-Filho G. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Chest. 2015 Sep;148(3):683-691. doi: 10.1378/chest.14-2953.

  PMID: 25950418 RESULT

• Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.

  PMID: 30736887 RESULT

• Leamari VM, Rodrigues AF, Camino Junior R, Luz JGC. Correlations between the Helkimo indices and the maximal mandibular excursion capacities of patients with temporomandibular joint disorders. J Bodyw Mov Ther. 2019 Jan;23(1):148-152. doi: 10.1016/j.jbmt.2017.12.008. Epub 2017 Dec 11.

  PMID: 30691742 RESULT

• Camacho M, Guilleminault C, Wei JM, Song SA, Noller MW, Reckley LK, Fernandez-Salvador C, Zaghi S. Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2018 Apr;275(4):849-855. doi: 10.1007/s00405-017-4848-5. Epub 2017 Dec 23.

  PMID: 29275425 RESULT

• Qiao M, Xie Y, Wolff A, Kwon J. Long term adherence to continuous positive Airway pressure in mild obstructive sleep apnea. BMC Pulm Med. 2023 Sep 1;23(1):320. doi: 10.1186/s12890-023-02612-3.

  PMID: 37658304 RESULT

• Iannella G, Pace A, Bellizzi MG, Magliulo G, Greco A, De Virgilio A, Croce E, Gioacchini FM, Re M, Costantino A, Casale M, Moffa A, Lechien JR, Cocuzza S, Vicini C, Caranti A, Marchese Aragona R, Lentini M, Maniaci A. The Global Burden of Obstructive Sleep Apnea. Diagnostics (Basel). 2025 Apr 25;15(9):1088. doi: 10.3390/diagnostics15091088.

  PMID: 40361906 RESULT

Related Links

• American Academy of Sleep Medicine Guidelines \| AASM
• Obstructive sleep apnoea/hypopnoea syndrome \| Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s \| Guidance \| NICE 2021

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy; Continuous Positive Airway Pressure

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; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Moussa Albert Riachy, MD

  Hotel Dieu de France, Saint Joseph University, Beirut, Lebanon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moussa Riachy, MD

CONTACT

+9613361672; moussa.riachy@hdf.usj.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Mandibular excursion assessors and polysomnography scorers will remain blinded to treatment allocation. Participants cannot be blinded to CPAP exposure; however, sham follow-up visits will mimic the intensity of OMT follow-up to reduce performance bias.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, four-arm parallel-group trial with a 2 × 2 factorial treatment structure comparing sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, and combined OMT plus CPAP plus standard of care in adults with mild-to-moderate obstructive sleep apnea; allocation 1:1:1:1, stratified by baseline OSA severity.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary results manuscript or, if no publication occurs, 12 months after study completion, and ending 5 years thereafter.
• Access Criteria: De-identified individual participant data and supporting documents will be made available to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the study investigators and sponsor institution for scientific merit, feasibility, consistency with participant consent, ethics requirements, and compliance with applicable data-protection regulations. Approved requestors will receive access only to the data necessary for the approved analyses, after signing a data access and confidentiality agreement. Data will be shared in de-identified form through a secure controlled-access process coordinated by the study team.