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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Sham Breathing Sessions; Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling; Behavioral: Orofacial Myofunctional Therapy; Device: Continuous Positive Airway Pressure

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 Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moussa Riachy, MD; Phone Number: +9613361672; Email: moussa.riachy@hdf.usj.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham + Standard of Care.; 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; Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.; 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.
Experimental: Orofacial Myofunctional Therapy + Standard of Care; 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: 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.; 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 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.
Active Comparator: CPAP + Standard of Care; 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.	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.; 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.
Experimental: Orofacial Myofunctional Therapy + CPAP + Standard of Care; 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: 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.; 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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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 (%).	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.	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.	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 (%).	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.	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).	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.	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.	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.	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).	Baseline and Week 12
Change in Neck Circumference	Change in neck circumference from baseline; expressed in millimeters (mm).	Baseline, Week 12, and Week 52
Change in Body Mass Index	Change in body mass index from baseline; expressed in kg/m².	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.	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.	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.	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.	Baseline and Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Moussa Albert Riachy, MD, Hotel Dieu de France, Saint Joseph University, Beirut, Lebanon

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Randomized Controlled Trial; Orofacial Myofunctional Therapy; Apnea-Hypopnea Index; Mild-to-Moderate Obstructive Sleep Apnea; Mandibular Excursion; George Gauge; Jaw Motion Analyser
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Dentistry; Continuous Positive Airway Pressure; Myofunctional Therapy
• Other Study ID Numbers: CEHDF-2740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No