An interventional study of MYOPAP Program in Excessive Daytime Sleepiness and Disorders of Excessive Somnolence, sponsored by Kuwait University. Completed at 1 site in Kuwait. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Kuwait University · Not applicable, Interventional, and Treatment
The aim of this clinical trial is to examine the feasibility, acceptability and safety of a 6-week intervention (MYOPAP) which includes oropharyngeal myofunctional therapy, physical activity guidance, and sleep hygiene education in university students aged 18 years and older with excessive daytime sleepiness (Epworth Sleepiness Scale score greater than 10). The study will also explore changes in daytime sleepiness following the intervention and the feasibility of the procedures needed to inform future controlled trail.
The main questions it aims to answer are:
Participants will:
Design and setting: single-arm, pre-post pilot feasibility trial conducted at the Faculty of Allied Health Sciences, Kuwait University
Screening and recruitment: students were screened using an online survey incorporating the Epworth Sleepiness Scale (ESS). Those with ESS score > 10 were classified as having excessive daytime sleepiness and were contacted sequentially, in order of survey completion until the predetermined sample size was reached.
Intervention: the MYOPAP program consists of three components delivered over 6 weeks:
Oropharyngeal myofunctional therapy, performed daily at home:
Physical activity guidance:
Sleep hygiene education:
Delivery and monitoring: Instructions was provided in person at baseline with written and video materials, supplemented by daily reminder messages and weekly follow-up phone calls. adherence was monitored using daily electronic polls.
Feasibility benchmarks: Feasibility was evaluated against a priori benchmarks including retention of at least 80% of enrolled participants and at least 70% of participants rating the intervention as acceptable. Recruitment was reported descriptively.
195 studies on the registry are indexed under Disorders of Excessive Somnolence; 33 are open to participants now.
This study's enrollment of 14 is below the median of 86 across 158 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →Kuwait University is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
University students with excessive daytime sleepiness (ESS \>10) who received the 6-week MYOPAP program ( home-based oropharyngeal myofunctional exercises, physical activity guidance, and sleep hygiene education) supported by daily reminder messages and weekly follow-up phone calls.
Behavioral: MYOPAP Program
A 6-week home-based multicomponent program delivered after an in-person instructional session with written and video materials. It consists of (1) seven oropharyngeal myofunctional exercises targeting the tongue, soft palate, and buccinator muscles, performed daily; (2) physical activity guidance including hourly movement breaks, nightly relaxation stretching, and brisk walking 3 days per week; and (3) sleep hygiene education including a consistent sleep-wake schedule, pre-sleep screen and caffeine restrictions, bedroom environment optimization, and paced relaxation breathing.
Retention Rate
Proportion of enrolled participants who completed the 6- week program.
Time frame: Baseline to week 6
Adherence to the exercise program
Proportion of participants who completed the myofunctional exercises on at least 3 days per week, monitored using daily electronic polls.
Time frame: week 1 to 6
Intervention acceptability
Proportion of participants who somewhat or completely agreed with each item of a 9-item post-intervention acceptability questionnaire (5-point Likert scale scored 0-4, from completely disagree to completely agree).
Time frame: Week 6
Number of participants with Adverse Events
Participants-reported adverse effects related to the intervention, recorded at weekly follow-up sessions.
Time frame: Weeks 1 to 6
Recruitment Rate
Proportion of eligible students (ESS\>10) contacted who consented and enrolled in the study. Reported descriptively because of the sequential, capped recruitment design.
Time frame: Recruitment period (3 weeks)
Change in Daytime Sleepiness
Change in ESS total score from baseline to week 6 (exploratory).
Time frame: Baseline and week 6
Plan to share: Yes — De-identified individual participant data underlying the published results will be available to qualified researchers upon reasonable request to the principal investigator, subject to approval by the HSC Ethics Committee for Student Research, Kuwait University.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Disorders of Excessive Somnolence →
Kuwait University