NCT07639229

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 5, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

RamadanSleep hygienePsychomotor vigilanceAthletic performanceSport-science studentsBehavioral interventionCognitive performance

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline and Ramadan week 4

  • Sleep Efficiency

    Sleep efficiency percentage (ratio of total sleep time to time in bed Ă— 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.

    Baseline and Ramadan week 4

  • 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.

    Baseline and Ramadan week 4

Secondary Outcomes (6)

  • Psychomotor Vigilance - Lapses

    Baseline and Ramadan week 4

  • Countermovement Jump Height

    Baseline and Ramadan week 4

  • Squat Jump Height

    Baseline and Ramadan week 4

  • Handgrip Strength

    Baseline and Ramadan week 4

  • Agility Performance

    Baseline and Ramadan week 4

  • +1 more secondary outcomes

Study Arms (2)

Experimental Group (Sleep Hygiene Education)

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

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.

Experimental Group (Sleep Hygiene Education)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Higher Institute of Sport and Physical Education of Sfax (ISSEP Sfax)

Sfax, Sfax Governorate, 3000, Tunisia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the behavioral nature of the sleep hygiene intervention, participants and the investigator delivering the educational session were unblinded. However, outcome assessors conducting cognitive (PVT) and physical performance tests, as well as data analysts, were blinded to group allocation to minimize measurement and analytical bias.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel-group pilot randomized controlled trial comparing a culturally adapted sleep hygiene education intervention to a control condition (usual habits). Participants were randomized 1:1 using computer-generated block randomization with allocation concealment via sealed envelopes. Outcome assessors conducting cognitive (PVT) and physical performance tests, as well as data analysts, were blinded to group allocation. Participants and the investigator delivering the educational session were unblinded due to the behavioral nature of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

February 10, 2025

Primary Completion

March 30, 2025

Study Completion

March 31, 2025

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations