An interventional study of Sham Breathing Sessions and Orofacial Myofunctional Therapy in Obstructive Sleep Apnea, sponsored by Saint-Joseph University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Treatment
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 168 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.
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.
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.
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.
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.
Time frame: Week 12
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)
Time frame: 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.
Time frame: 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.
Time frame: 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 (%).
Time frame: 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.
Time frame: 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.
Time frame: 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 (%).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and Week 12
Change in Neck Circumference
Change in neck circumference from baseline; expressed in millimeters (mm).
Time frame: Baseline, Week 12, and Week 52
Change in Body Mass Index
Change in body mass index from baseline; expressed in kg/m².
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
Participants With at Least 1 Treatment-Emergent Adverse Event
Number of participants with at least 1 adverse event (e.g., worsening of daytime sleepiness or sleep quality, temporomandibular pain or functional limitation, non-tolerance to CPAP or any others adverse events) occurring after initiation of study treatment; expressed as number of participants.
Time frame: Baseline to Week 52
Participants Who Discontinued Assigned Treatment Due to Adverse Events or Intolerance
Number of participants who discontinued CPAP or orofacial myofunctional therapy because of adverse events or treatment intolerance; expressed as number of participants.
Time frame: Baseline to Week 52
Participants Withdrawn From the Study Due to Adverse Events
Number of participants withdrawn from the study because of adverse events (e.g., worsening of daytime sleepiness or sleep quality, temporomandibular pain or functional limitation or any others adverse events) ; expressed as number of participants.
Time frame: Baseline to Week 52
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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