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

Official title

Isolated and Combined Effects of Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure on the Apnea-Hypopnea Index and Mandibular Excursion in Adults With Mild-to-Moderate Obstructive Sleep Apnea: The OMPACT-OSA Randomized Controlled Trial

Overview

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.

Detailed description

Obstructive sleep apnea (OSA) is a common chronic disorder associated with substantial cardiovascular, metabolic, and neurocognitive morbidity. Continuous positive airway pressure (CPAP) remains the standard treatment, but adherence is often suboptimal, especially in patients with mild-to-moderate OSA. Orofacial myofunctional therapy (OMT) is a promising non-pharmacological approach that may improve upper-airway function and reduce disease severity. However, few randomized studies have compared OMT and CPAP within the same factorial design, and limited data are available regarding the relationship between mandibular excursion and improvement in OSA severity. OMPACT-OSA was developed to address these gaps in a Lebanese academic clinical setting.

OMPACT-OSA is a randomized, controlled, four-arm parallel-group clinical trial with a 2 x 2 factorial treatment structure and 1:1:1:1 allocation. Randomization will be stratified by baseline OSA severity. Participants will be assigned to sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, or combined OMT plus CPAP plus standard of care. Mandibular excursion assessors and polysomnography scorers will remain blinded to treatment allocation, although participants cannot be blinded to CPAP exposure. Sham follow-up visits are used to mimic the intensity of OMT follow-up and reduce performance bias. The trial includes a 12-week supervised intervention phase followed by a 40-week observational phase, for a total duration of 52 weeks.

The primary objective is to compare the efficacy of OMT alone, CPAP alone, and combined OMT plus CPAP on the severity of mild-to-moderate OSA at Week 12. The primary endpoint is apnea-hypopnea index (AHI) at Week 12 assessed by sleep recording. The key secondary endpoint is change in mandibular excursion from baseline to Week 12. Additional outcomes will assess whether baseline mandibular excursion, Mallampati score, and baseline respiratory-event phenotype (including apnea index, hypopnea index, and hypopnea-predominant versus apnea-predominant OSA) predict response to OMT, sleep quality, dento-occlusal effects, anthropometric measures, therapeutic adherence, treatment persistence, nocturnal respiratory parameters, and safety and tolerability outcomes.

Eligible participants are adults with mild-to-moderate OSA confirmed by Type I polysomnography, no previous treatment with CPAP or OMT, and sufficient protrusive excursion to allow study procedures. Participants with severe OSA or urgent need for CPAP, obesity hypoventilation syndrome or chronic ventilatory failure, unstable major cardiovascular disease, uncontrolled diabetes requiring treatment intensification, upper-airway neurological or ENT disease, craniofacial abnormalities, recent maxillofacial surgery, temporomandibular pain preventing exercises, active periodontitis, pregnancy, foreseeable non-adherence, or ongoing CPAP/OMT at inclusion will be excluded.

The sham arm consists of placebo breathing sessions combined with standard of care. The OMT arm consists of a structured 12-week program with 3 sessions per day, each lasting approximately 8 minutes, together with adherence support. The CPAP arm consists of CPAP treatment over 12 weeks, with technical and adherence support. The combined arm receives both full OMT and CPAP concurrently. Standard of care is provided uniformly to all participants and includes standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.

Participants will undergo baseline and follow-up assessments, including sleep studies, mandibular excursion measurements using the George Gauge and Jaw Motion Analyser, insomnia severity assessment with the ISI, review of medications affecting sleep or respiratory drive, focused evaluation of comorbid conditions likely to confound sleep-related symptoms, and Mallampati classification. Baseline polysomnography data, including apnea index, hypopnea index, and respiratory-event phenotype, will be extracted, alongside anthropometric and dento-occlusal evaluation and adherence monitoring. After Week 12, all participants enter observational follow-up through Week 52 to evaluate durability of treatment effects under real-world conditions, document treatment persistence and symptom recurrence, and prospectively record treatment resumption, crossovers, and other protocol-relevant therapeutic changes.

The final planned sample size is 168 participants, corresponding to 42 participants per arm. The primary analysis population is the intention-to-treat population. The study will be analyzed primarily as a four-arm randomized trial with a factorial structure, with prespecified sensitivity and exploratory analyses. An independent monitoring committee will be established to help ensure participant safety, proper data collection, and compliance with study procedures.

Interventions

• Behavioral Sham Breathing Sessions
  Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.
• Behavioral Orofacial Myofunctional Therapy
  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
• Device Continuous Positive Airway Pressure
  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.
• Behavioral Standard of Care Sleep-Hygiene and Lifestyle Counseling
  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.

Primary outcome measures

• Apnea-Hypopnea Index (AHI) [Time frame: Week 12]

Secondary outcome measures (12)

• Change in Mandibular Excursion [Time frame: Baseline and Week 12]
• Change in Apnea-Hypopnea Index (AHI) Over Follow-up [Time frame: Baseline, Week 12, and Week 52]
• Change in Oxygen Desaturation Index (ODI) [Time frame: Baseline, Week 12, and Week 52]
• Change in Oxygen Saturation Nadir (SpO2 nadir) [Time frame: Baseline, Week 12, and Week 52]
• Calibration of Type III Polygraphy-Derived AHI Against Type I Polysomnography-Derived AHI [Time frame: Week 12]
• Continuous Positive Airway Pressure (CPAP) Adherence [Time frame: Week 6, Week 12, Week 36, and Week 52]
• Orofacial Myofunctional Therapy Adherence [Time frame: Week 6, Week 12, Week 36, and Week 52]
• Epworth Sleepiness Scale Total Score [Time frame: Baseline, Week 6, Week 12, Week 36, and Week 52]
• Pittsburgh Sleep Quality Index Global Score [Time frame: Baseline, Week 6, Week 12, Week 36, and Week 52]
• Temporomandibular Pain Intensity [Time frame: Baseline, Week 12, and Week 52]
• Helkimo Clinical Dysfunction Index Score [Time frame: Baseline, Week 12, and Week 52]
• Helkimo Anamnestic Index Category [Time frame: Baseline, Week 12, and Week 52]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Ongoing CPAP or OMT at inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07539870 · CEHDF-2740

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗