ClinicalTrials.gg
CompletedNCT07639229SHIRUpdated Jun 12, 2026

Sleep Hygiene During Ramadan

An interventional study of Culturally Adapted Sleep Hygiene Education Program in Sleep Disruption, Sleep Hygiene and Ramadan Fasting, sponsored by The Higher Institute of Sport and Physical Education of Sfax. Completed at 1 site in Tunisia. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by The Higher Institute of Sport and Physical Education of Sfax · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2025, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
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Study summary

Ramadan fasting often disrupts sleep patterns, which can affect alertness and physical performance in student-athletes. This study tested whether a brief sleep education program designed for Ramadan could help improve sleep quality and maintain performance.

Sixty-four male sport-science students who planned to fast during Ramadan were randomly assigned to one of two groups. The first group received a 45-minute educational session about sleep hygiene specifically adapted to Ramadan practices (timing of sleep around evening and pre-dawn meals, managing light exposure, limiting caffeine and screen time before bed). They also received weekly text message reminders and completed short weekly checklists about their sleep habits. The second group continued their usual routines without any intervention.

Participants wore activity monitors on their wrist to track sleep throughout the study. They also completed computerized tests of attention and reaction time, as well as physical performance tests (jumping, handgrip strength, agility) before Ramadan and during the final week of fasting.

The researchers found that students who received the sleep education maintained better sleep duration and quality during Ramadan compared to those who did not receive the program. They also showed better attention, faster reaction times, and better preservation of physical performance. This suggests that simple, culturally-adapted sleep education can help student-athletes maintain their health and performance during Ramadan.

Read the detailed description

This pilot randomized controlled trial investigated the effects of a culturally adapted sleep hygiene education program on objectively measured sleep, psychomotor vigilance, and physical performance during Ramadan in male sport-science students.

STUDY DESIGN AND PARTICIPANTS:

Sixty-four male sport-science students (aged 18-30 years) from the Higher Institute of Sport and Physical Education of Sfax, Tunisia, who intended to observe Ramadan fasting, were randomly allocated to either an intervention group (n=32) or a control group (n=32). Randomization was performed using computer-generated block randomization with allocation concealment via sealed envelopes.

INTERVENTION:

Participants in the intervention group received a single 45-minute educational session during the week preceding Ramadan. The session addressed sleep hygiene strategies specifically adapted to Ramadan constraints, including: (1) maintaining consistent sleep schedules compatible with suhoor (pre-dawn meal) and iftar (evening meal) timing, (2) managing evening light exposure and screen use, (3) regulating caffeine intake, (4) optimizing the sleep environment, and (5) planning sleep consolidation strategies. Participants received written educational materials and weekly text message reminders (Monday and Thursday) throughout Ramadan. Adherence was monitored using weekly self-report checklists returned each Saturday. The control group received no intervention and maintained their usual daily habits.

OUTCOME MEASURES:

Primary outcomes were sleep parameters assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. Derived parameters included total sleep time, sleep efficiency, and wake after sleep onset (WASO). A minimum of 5 valid nights was required for analysis.

Secondary outcomes assessed at baseline and Ramadan week 4 included:

  • Psychomotor vigilance: 10-minute Psychomotor Vigilance Test (PVT) measuring mean reaction time and number of lapses (reaction times >500 ms)
  • Neuromuscular performance: countermovement jump (CMJ), squat jump (SJ), handgrip strength, and agility (change-of-direction test)

COVARIATES:

Baseline values of all outcome variables were included as covariates. Additional covariates assessed at baseline included chronotype (reduced Morningness-Eveningness Questionnaire), daily caffeine intake (cups/day), and evening screen exposure (minutes in the last hour before bedtime).

STATISTICAL ANALYSIS:

Changes in sleep parameters were analyzed using linear mixed-effects models with group, time, and group × time interaction as fixed effects, and participant as a random effect. Baseline values were included as covariates. For cognitive and physical performance outcomes at week 4, analysis of covariance (ANCOVA) was used with group as the fixed factor and baseline values as covariates. Effect sizes were reported as partial eta squared (η²p) for ANCOVA models and Hedges' g for adjusted between-group comparisons. Statistical significance was set at p \< 0.05.

STUDY PERIOD:

Data collection occurred from February 10, 2025 (baseline) to March 31, 2025 (end of Ramadan 1446 AH, corresponding to March 1-30, 2025 in Tunisia).

ETHICAL CONSIDERATIONS:

The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. The protocol was reviewed by the Institutional Scientific Committee of ISSEPS Sfax and determined to be exempt from formal external ethics committee review under Tunisian regulations governing minimal-risk behavioral research.

This trial was registered retrospectively at ClinicalTrials.gov.

02

Conditions studied

  • Sleep Disruption
  • Sleep Hygiene
  • Ramadan Fasting

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Keywords

  • Ramadan
  • Sleep hygiene
  • Psychomotor vigilance
  • Athletic performance
  • Sport-science students
  • Behavioral intervention
  • Cognitive performance
03

In context

Sleep Hygiene

126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.

This study's enrollment of 64 is close to the median of 66 across 113 interventional studies indexed under Sleep Hygiene.

Browse Sleep Hygiene studies →

Lead sponsor

The Higher Institute of Sport and Physical Education of Sfax is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Male sports science students aged 18 to 30 years
  • Intend to fast for the full duration of Ramadan
  • No history of diagnosed sleep disorders or medical conditions affecting sleep or cognition
  • Free from musculoskeletal injuries that could limit physical performance tests

Exclusion criteria

Exclusion Criteria:

  • Chronic sleep disorders (e.g., insomnia, obstructive sleep apnea)
  • Use of medications known to affect sleep or alertness
  • Failure to complete the Ramadan fasting period
  • Non-compliance with actigraphy monitoring procedures
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Experimental Group (Sleep Hygiene Education)

    Participants receive a single 45-minute culturally adapted sleep hygiene education session prior to Ramadan, followed by written materials, weekly adherence checklists, and bi-weekly SMS reminders throughout Ramadan.

    Behavioral: Culturally Adapted Sleep Hygiene Education Program

  • No intervention
    Control Group

    Participants receive no sleep hygiene education or reminders and are instructed to maintain their usual daily routines and sleep habits throughout the Ramadan period.

Interventions

  • BehavioralCulturally Adapted Sleep Hygiene Education Program

    A structured educational session addressing sleep scheduling relative to suhoor/iftar, evening light and screen exposure management, caffeine intake regulation, and sleep environment optimization. Delivered as a single 45-minute session before Ramadan, supplemented with written guidelines, weekly self-report checklists, and bi-weekly SMS reminders.

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What researchers measure

Primary outcomes

  1. Total Sleep Time

    Total sleep time in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.

    Time frame: Baseline and Ramadan week 4

  2. Sleep Efficiency

    Sleep efficiency percentage (ratio of total sleep time to time in bed × 100), assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.

    Time frame: Baseline and Ramadan week 4

  3. Wake After Sleep Onset (WASO)

    Wake after sleep onset in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.

    Time frame: Baseline and Ramadan week 4

Secondary outcomes

  1. Psychomotor Vigilance - Lapses

    Number of lapses (reaction times ≥500 milliseconds) on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4.

    Time frame: Baseline and Ramadan week 4

  2. Countermovement Jump Height

    Lower-limb explosive power assessed by countermovement jump (CMJ) height in centimeters. Best performance of 3 maximal trials retained for analysis.

    Time frame: Baseline and Ramadan week 4

  3. Squat Jump Height

    Lower-limb explosive power assessed by squat jump (SJ) height in centimeters. Best performance of 3 maximal trials retained for analysis.

    Time frame: Baseline and Ramadan week 4

  4. Handgrip Strength

    Maximal handgrip strength in kilograms measured using a handgrip dynamometer. Best performance of 3 maximal contractions with dominant hand retained for analysis.

    Time frame: Baseline and Ramadan week 4

  5. Agility Performance

    Change-of-direction agility test performance time in seconds. Best performance of 2 trials retained for analysis.

    Time frame: Baseline and Ramadan week 4

  6. Psychomotor Vigilance - Mean Reaction Time

    Mean reaction time in milliseconds on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4 under standardized conditions.

    Time frame: Baseline and Ramadan week 4

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Study locations

1 site
  • Higher Institute of Sport and Physical Education of Sfax (ISSEP Sfax)
    Sfax, Sfax Governorate 3000, Tunisia
08

References and documents

Publications

  • Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142. PubMed 24179309 ↗

Individual participant data

Plan to share: Yes — De-identified participant data will be made available. This includes demographic and anthropometric data, objective sleep outcomes derived from actigraphy (total sleep time, sleep efficiency, wake after sleep onset), psychomotor vigilance test (PVT) results (mean reaction time, lapses), and physical performance test results (countermovement jump, squat jump, handgrip strength, and agility).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be available within 3 months following the publication of the results in a peer-reviewed journal and will remain available for 5 years.

Access criteria: Data can be requested by researchers with a specific, scientifically sound research proposal. Requests should be submitted via email to the corresponding author (kais.elabed@gmail.com). A data use agreement may be required prior to sharing.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Mar 2025, 1 month.

Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 1 month is below that.

Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2026
First posted
Jun 10, 2026
StartActual
Feb 10, 2025
Primary completionActual
Mar 30, 2025
CompletionActual
Mar 31, 2025
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07639229
Lead sponsor
The Higher Institute of Sport and Physical Education of Sfax
Responsible party
Kais Elabed (Principal Investigator, The Higher Institute of Sport and Physical Education of Sfax) — Principal investigator
First posted
Jun 10, 2026
Start date
Feb 10, 2025
Primary completion
Mar 30, 2025
Completion
Mar 31, 2025
Last update
Jun 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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