Obstructive Sleep ApneaOMPACT-OSANCT07539870
Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obstructive Sleep Apnea
A study testing Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by Saint-Joseph University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sham Breathing Sessions, Orofacial Myofunctional Therapy, Continuous Positive Airway Pressure, Standard of Care Sleep-Hygiene and Lifestyle Counseling
- 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
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Breathing SessionsBehavioural
Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.
Orofacial Myofunctional TherapyBehavioural
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.
Continuous Positive Airway PressureDevice
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.
Standard of Care Sleep-Hygiene and Lifestyle CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Orofacial Myofunctional Therapy; Device: Continuous Positive Airway Pressure; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (19)
Change in Mandibular Excursion
Change in mandibular excursion (mm) between baseline and Week 12, defined as the mean of 3 George Gauge measurements, expressed in millimeters (mm)
Measured: Baseline and Week 12
Change in Apnea-Hypopnea Index (AHI) Over Follow-up
Change in AHI from baseline to follow-up visits, assessed by sleep recording and scored according to the prespecified study scoring criteria; expressed in events/hour.
Measured: Baseline, Week 12, and Week 52
Change in Oxygen Desaturation Index (ODI)
Change in oxygen desaturation index from baseline, assessed by overnight sleep recording; expressed in events/hour.
Measured: Baseline, Week 12, and Week 52
Change in Oxygen Saturation Nadir (SpO2 nadir)
Change in lowest overnight oxygen saturation from baseline, assessed by overnight sleep recording; expressed in percent (%).
Measured: Baseline, Week 12, and Week 52
Calibration of Type III Polygraphy-Derived AHI Against Type I Polysomnography-Derived AHI
In a prespecified 20% subsample of the study population, apnea-hypopnea index measured by Type III polygraphy will be compared with apnea-hypopnea index measured by Type I polysomnography using paired recordings obtained at the same assessment time point, in order to derive a calibration equation. This calibration will then be applied to Type III polygraphy-derived measurements in the remaining participants. AHI will be expressed in events/hour.
Measured: Week 12
Continuous Positive Airway Pressure (CPAP) Adherence
Average nightly CPAP use recorded from device data; use categories (<4 h/night, 4-6 h/night, >6 h/night), expressed in hours/night.
Measured: Week 6, Week 12, Week 36, and Week 52
Orofacial Myofunctional Therapy Adherence
Adherence to prescribed orofacial myofunctional therapy sessions; expressed as percent of prescribed sessions completed (%).
Measured: Week 6, Week 12, Week 36, and Week 52
Epworth Sleepiness Scale Total Score
Daytime sleepiness assessed using the Epworth Sleepiness Scale. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline, Week 6, Week 12, Week 36, and Week 52
Pittsburgh Sleep Quality Index Global Score
Sleep quality assessed using the Pittsburgh Sleep Quality Index. Scores range from 0 to 21, with higher scores indicating worse sleep quality (PSQI).
Measured: Baseline, Week 6, Week 12, Week 36, and Week 52
Temporomandibular Pain Intensity
Temporomandibular pain assessed using a Visual Analogue Scale; score range from 0 to 10, with higher scores indicating worse pain.
Measured: Baseline, Week 12, and Week 52
Helkimo Clinical Dysfunction Index Score
Dento-occlusal dysfunction assessed using the Helkimo Clinical Dysfunction Index. Total scores range from 0 to 25, with higher scores indicating greater dysfunction.
Measured: Baseline, Week 12, and Week 52
Helkimo Anamnestic Index Category
Subjective temporomandibular symptoms assessed using the Helkimo Anamnestic Index; reported as categorical classification: Ai0 = no symptoms, AiI = mild symptoms, and AiII = severe symptoms.
Measured: Baseline, Week 12, and Week 52
Head-to-Head Comparison of Mandibular Excursion Measurements Using George Gauge and JMA Optic
Head-to-head comparison of mandibular excursion measurements obtained with the George Gauge and the JMA Optic at the same assessment time point; between-device differences will be evaluated using paired measurements and expressed in millimeters (mm).
Measured: Baseline and Week 12
Change in Neck Circumference
Change in neck circumference from baseline; expressed in millimeters (mm).
Measured: Baseline, Week 12, and Week 52
Change in Body Mass Index
Change in body mass index from baseline; expressed in kg/m².
Measured: Baseline, Week 12, and Week 52
Proportion of Participants With CPAP Response at Week 12
CPAP response is defined as a reduction of more than 50% in apnea-hypopnea index from baseline to Week 12. Exploratory analyses will assess the association of baseline clinical variables, including sex and body mass index, with treatment response.
Measured: Baseline and Week 12
Association Between Baseline Mallampati Score and OMT Response
Association between baseline Mallampati score and response to orofacial myofunctional therapy; where treatment response is defined as a reduction greater than 50% in apnea-hypopnea index from baseline to Week 12, and the association will be evaluated using logistic regression and reported as an odds ratio.
Measured: Baseline and Week 12
Association Between Baseline OSA Event Phenotype and OMT Response
Association between baseline obstructive sleep apnea event phenotype (hypopnea-predominant versus apnea-predominant) and response to orofacial myofunctional therapy, where treatment response is defined as a reduction greater than 50% in apnea-hypopnea index from baseline to Week 12, and the association will be evaluated using logistic regression and reported as an odds ratio.
Measured: Baseline and Week 12
Association Between Baseline Mandibular Excursion and OMT Response
Association between baseline mandibular excursion and response to orofacial myofunctional therapy (OMT) at Week 12, where treatment response is defined as a reduction greater than 50% in apnea-hypopnea index (AHI) from baseline to Week 12; mandibular excursion is expressed in millimeters (mm), and the association will be evaluated using logistic regression and reported as an odds ratio.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moussa Albert Riachy, MD, Principal investigator, Hotel Dieu de France, Saint Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539870
- Sponsor's protocol ID
- CEHDF-2740
- Acronym
- OMPACT-OSA
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications from this trial will be shared. This will include baseline demographic and clinical characteristics, treatment allocation, adherence data for OMT and/or CPAP, sleep-study variables including apnea-hypopnea index (AHI), oxygen desaturation index (ODI), oxygen saturation nadir, mandibular excursion measurements, questionnaire data including ESS and PSQI scores, dento-occlusal and temporomandibular assessment data, anthropometric measures, and follow-up outcome data collected at the protocol-defined study visits.
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.
PubMed 25348130Guimaraes 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.
PubMed 19234106Ieto 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.
PubMed 25950418Patil 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.
PubMed 30736887Leamari 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.
PubMed 30691742Camacho 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.
PubMed 29275425Qiao 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.
PubMed 37658304Iannella 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.
PubMed 40361906
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07539870
- Acronym / sponsor ID
- OMPACT-OSA / CEHDF-2740
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sham + Standard of Care. | Sham comparator | Behavioral: Sham Breathing Sessions, Behavioral: Standard of Care Sleep-Hygiene and Lifestyle CounselingParticipants 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. |
| Orofacial Myofunctional Therapy + Standard of Care | Experimental | Behavioral: Orofacial Myofunctional Therapy, Behavioral: Standard of Care Sleep-Hygiene and Lifestyle CounselingParticipants 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. |
| CPAP + Standard of Care | Active comparator | Device: Continuous Positive Airway Pressure, Behavioral: Standard of Care Sleep-Hygiene and Lifestyle CounselingParticipants 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. |
| Orofacial Myofunctional Therapy + CPAP + Standard of Care | Experimental | Behavioral: Orofacial Myofunctional Therapy, Device: Continuous Positive Airway Pressure, Behavioral: Standard of Care Sleep-Hygiene and Lifestyle CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Breathing SessionsPlacebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm. | Behavioural | Sham + Standard of Care. |
| Orofacial Myofunctional TherapyStructured 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. | Behavioural | Orofacial Myofunctional Therapy + CPAP + Standard of Care, Orofacial Myofunctional Therapy + Standard of Care |
| Continuous Positive Airway PressureParticipants 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. | Device | CPAP + Standard of Care, Orofacial Myofunctional Therapy + CPAP + Standard of Care |
| Standard of Care Sleep-Hygiene and Lifestyle CounselingStandardized 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. | Behavioural | CPAP + Standard of Care, Orofacial Myofunctional Therapy + CPAP + Standard of Care, Orofacial Myofunctional Therapy + Standard of Care, Sham + Standard of Care. |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Week 12
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.
19 secondary outcomes
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
Head-to-Head Comparison of Mandibular Excursion Measurements Using George Gauge and JMA Optic
Time frame: Baseline and Week 12
Change in Neck Circumference
Time frame: Baseline, Week 12, and Week 52
Change in Body Mass Index
Time frame: Baseline, Week 12, and Week 52
Proportion of Participants With CPAP Response at Week 12
Time frame: Baseline and Week 12
Association Between Baseline Mallampati Score and OMT Response
Time frame: Baseline and Week 12
Association Between Baseline OSA Event Phenotype and OMT Response
Time frame: Baseline and Week 12
Association Between Baseline Mandibular Excursion and OMT Response
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 25348130Camacho 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.
- Results publication: PubMed 19234106Guimaraes 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.
- Results publication: PubMed 25950418Ieto 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.
- Results publication: PubMed 30736887Patil 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.
- Results publication: PubMed 30691742Leamari 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.
- Results publication: PubMed 29275425Camacho 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.
- Results publication: PubMed 37658304Qiao 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.
- Results publication: PubMed 40361906Iannella 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.
- American Academy of Sleep Medicine Guidelines \| AASMLink provided by the sponsor.
- Obstructive sleep apnoea/hypopnoea syndrome \| Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s \| Guidance \| NICE 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications from this trial will be shared. This will include baseline demographic and clinical characteristics, treatment allocation, adherence data for OMT and/or CPAP, sleep-study variables including apnea-hypopnea index (AHI), oxygen desaturation index (ODI), oxygen saturation nadir, mandibular excursion measurements, questionnaire data including ESS and PSQI scores, dento-occlusal and temporomandibular assessment data, anthropometric measures, and follow-up outcome data collected at the protocol-defined study visits.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moussa Albert Riachy, MD principal investigator
Hotel Dieu de France, Saint Joseph University, Beirut, Lebanon
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by Saint-Joseph University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moussa Riachy, MD (+9613361672, moussa.riachy@hdf.usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539870, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.