Excessive Daytime SleepinessMYOPAPNCT07879859
Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime Sleepiness
A study testing MYOPAP Program in people with Excessive Daytime Sleepiness and Disorders of Excessive Somnolence, run by Kuwait University at 1 site in Kuwait.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Daytime Sleepiness, Disorders of Excessive Somnolence
- What is being tested?
- MYOPAP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteKuwait
- Study dates
- 15 Feb 2026to 29 Mar 2026
- Phase
- Interventional
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
- Undergraduate student enrolled in a college of the Health Sciences Center, Kuwait University
- Epworth Sleepiness Scale (ESS) score greater than 10 on the screening questionnaire
- Willing to participate in the 6-week MYOPAP program and the weekly follow-up sessions
Who cannot join
- ESS score of 10 or less
- Current participation in a sleep-related treatment program (e.g., continuous positive airway pressure, oral appliance therapy, or supervised oropharyngeal therapy)
- Known craniofacial, oropharyngeal, or neuromuscular condition that may limit performance of myofunctional exercises
- Self-reported medical or psychiatric condition affecting sleep
- Inability to understand or follow the study instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a 6-Week MYOPAP Intervention for Students With Excessive Daytime Sleepiness
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:
Read more
- What proportion of participants complete the intervention?
- What proportion adhere to the home exercises (at least 3 days per week)?
- Do participants find the intervention acceptable, and what adverse events occur?
Participants will:
- Attend one in-person session for consent, assessment, and instructions
- Perform myofunctional exercises at home daily for 6 weeks
- Follow physical activity and sleep hygiene recommendations
- Report adherence through daily polls and weekly check-ins
- Complete the Epworth Sleepiness Scale and an acceptability questionnaire at week 6
Read the detailed description
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:
- Tongue-to-palate suction hold: 10 repetitions with 5-second holds, twice daily
- Anterior-to-posterior tongue slide: 10-15 repetitions, once daily
- Posterior tongue press: 10-15 repetitions, once daily
- Soft palate vowel phonation (nasal inhalation followed by a prolonged "A" sound): 10 repetitions, once daily
- Buccinator suction: 10 repetitions, once daily
- Buccinator resistance exercise: 5 repetitions per side, once daily
- Alternating bilateral mastication with the tongue on the palate and lips sealed: at every meal
- Physical activity guidance:
- Movement breaks: 2-3 minutes per hour during sedentary study periods
- Pre-sleep relaxation stretching: 5-10 minutes nightly
- Moderate-intensity brisk walking: 20-30 minutes, 3 days/week
- Sleep hygiene education:
- Consistent sleep-wake schedule (within 30 minutes daily)
- No screen use 60 minutes before sleep
- No caffeine within 6 hours of bedtime
- Bedroom environment optimization (quiet, dark, cool; phone away from bed)
- Paced relaxation breathing (4-4-6 pattern): 5 minutes nightly
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.
- Being tested
- MYOPAP Program
- Keywords
- Myofunctional therapy, Oropharyngeal Exercises, Sleep Hygiene, Physical Activity, Epworth Sleepiness Scale, University Students, Feasibility Studies, Pilot Study
- Medical subject headings
- Disorders of Excessive Somnolence, Sleep Hygiene, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYOPAP ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MYOPAP Intervention | Experimental | 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. Receives: Behavioral: MYOPAP Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Proportion of enrolled participants who completed the 6- week program.
Measured: 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.
Measured: 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).
Measured: Week 6
Number of participants with Adverse Events
Participants-reported adverse effects related to the intervention, recorded at weekly follow-up sessions.
Measured: 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.
Measured: Recruitment period (3 weeks)
Secondary outcomes (1)
Change in Daytime Sleepiness
Change in ESS total score from baseline to week 6 (exploratory).
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Feb 2026
- Primary completion29 Mar 2026
- Study completion29 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Alemairi, Kuwait University
- Investigators
- Dr. Maryam Alemairi, PT, PhD, Principal investigator, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879859
- Sponsor's protocol ID
- FAHS-PT9
- Acronym
- MYOPAP
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.