- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07639229
Sleep Hygiene During Ramadan (SHIR)
Effects of a Culturally Adapted Sleep Hygiene Intervention on Sleep, Vigilance, and Physical Performance During Ramadan in Male Sports Science Students: A Randomized Controlled Trial
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Sfax Governorate
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Sfax, Sfax Governorate, Tunisko, 3000
- Higher Institute of Sport and Physical Education of Sfax (ISSEP Sfax)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
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.
|
|
Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Total Sleep Time
Časové okno: Baseline and Ramadan week 4
|
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.
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Baseline and Ramadan week 4
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Sleep Efficiency
Časové okno: Baseline and Ramadan week 4
|
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.
|
Baseline and Ramadan week 4
|
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Wake After Sleep Onset (WASO)
Časové okno: Baseline and Ramadan week 4
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Psychomotor Vigilance - Lapses
Časové okno: Baseline and Ramadan week 4
|
Number of lapses (reaction times ≥500 milliseconds) on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4.
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Baseline and Ramadan week 4
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Countermovement Jump Height
Časové okno: Baseline and Ramadan week 4
|
Lower-limb explosive power assessed by countermovement jump (CMJ) height in centimeters.
Best performance of 3 maximal trials retained for analysis.
|
Baseline and Ramadan week 4
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Squat Jump Height
Časové okno: Baseline and Ramadan week 4
|
Lower-limb explosive power assessed by squat jump (SJ) height in centimeters.
Best performance of 3 maximal trials retained for analysis.
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Baseline and Ramadan week 4
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Handgrip Strength
Časové okno: Baseline and Ramadan week 4
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Maximal handgrip strength in kilograms measured using a handgrip dynamometer.
Best performance of 3 maximal contractions with dominant hand retained for analysis.
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Baseline and Ramadan week 4
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Agility Performance
Časové okno: Baseline and Ramadan week 4
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Change-of-direction agility test performance time in seconds.
Best performance of 2 trials retained for analysis.
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Baseline and Ramadan week 4
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Psychomotor Vigilance - Mean Reaction Time
Časové okno: Baseline and Ramadan week 4
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Mean reaction time in milliseconds on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4 under standardized conditions.
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Baseline and Ramadan week 4
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Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ISSEPS_SleepRamadan_2025
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