- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07802093
Does Wearing Compression Garments Affect Sleep in Soccer Players
Does Wearing Compression Garments Affect Sleep in Soccer Players? A Randomized-controlled Cross-over Study From a Professional Soccer Club Academy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This randomized controlled crossover study was conducted in young elite male soccer players from a professional soccer club academy to investigate the effects of nocturnal compression garments on sleep quantity and quality.
The study was conducted over four consecutive weeks. During the first week, all participants completed a baseline control condition without wearing any garment during the night. This baseline condition was always performed first and was not randomized. During the following three weeks, participants completed three garment conditions in a randomized order: full-length compression leggings, compression calf sleeves, and non-compressive placebo garments. Each condition was maintained for seven consecutive nights.
Participants were instructed to put on the assigned garment approximately two hours before bedtime, wear it throughout the night, and remove it after waking. The placebo garment was designed to provide a similar wearing experience without applying meaningful compression.
Sleep was assessed objectively using wrist actigraphy and subjectively using self-reported sleep measures. Objective sleep variables included total sleep time, time in bed, sleep latency, sleep efficiency, and the number of nocturnal awakenings.
To limit potential confounding factors, external and internal training loads, perceived stress, fatigue and muscle soreness, pre-sleep nutritional intake, and nocturnal thermal conditions were monitored throughout the experimental period. The study was conducted under standardized living and training conditions within the professional soccer academy environment.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Avion, France, 62210
- Centre technique et sportif de la Gaillette Gervais Martel
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Residence at the professional soccer academy throughout the study period.
- Abstinence from tobacco and alcohol throughout the study period.
- No caffeine intake within 12 hours before bedtime.
- Absence of sleep deficit at inclusion.
- Absence of illness at inclusion.
Exclusion Criteria:
- Sustaining an injury during the study period.
- Exposure to a training load substantially different from that of the rest of the group.
- Development or presence of a sleep deficit during the study period.
- Failure to consume the standardized evening meal provided at the academy cafeteria.
- Consumption of caffeine, tobacco, or alcohol during the study period.
- Removal of the assigned garment or actigraphy device during the night.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Sequence 1: Leggings - Calf Sleeves - Placebo
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Participants wore fullcompression leggings from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore compression calf sleeves from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore visually similar non-compressive placebo garments from approximately two hours before bedtime until waking for seven consecutive nights.
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Expérimental: Sequence 2: Calf Sleeves - Placebo - Leggings
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Participants wore fullcompression leggings from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore compression calf sleeves from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore visually similar non-compressive placebo garments from approximately two hours before bedtime until waking for seven consecutive nights.
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Expérimental: Sequence 3: Placebo - Leggings - Calf Sleeves
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Participants wore fullcompression leggings from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore compression calf sleeves from approximately two hours before bedtime until waking for seven consecutive nights.
Participants wore visually similar non-compressive placebo garments from approximately two hours before bedtime until waking for seven consecutive nights.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total Sleep Time
Délai: Assessed nightly during each 7-night condition
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Assessed nightly during each 7-night condition
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Time in Bed
Délai: Assessed nightly during each 7-night condition
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Assessed nightly during each 7-night condition
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Sleep Latency
Délai: Assessed nightly during each 7-night condition
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Assessed nightly during each 7-night condition
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Mean Sleep Efficiency Assessed by Wrist Actigraphy
Délai: Measured nightly and averaged across the 7 consecutive nights of each condition
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Sleep efficiency was assessed by wrist actigraphy and calculated as the percentage of time in bed spent asleep.
Nightly sleep efficiency values were averaged across the seven consecutive nights of each experimental condition.
Higher values indicate greater sleep efficiency.
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Measured nightly and averaged across the 7 consecutive nights of each condition
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Number of Nocturnal Awakenings
Délai: Assessed nightly during each 7-night condition
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Assessed nightly during each 7-night condition
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Subjective Sleep Quality Assessed Using the Sleep Item of the Hooper Questionnaire
Délai: Assessed nightly during each 7-night condition
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Subjective sleep quality was assessed using the sleep-quality item of the Hooper Questionnaire (Hooper et al., 1995).
Participants rated the quality of the previous night's sleep on a 7-point Likert-type scale ranging from 1 (very, very good) to 7 (very, very bad), with higher scores indicating poorer perceived sleep quality.
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Assessed nightly during each 7-night condition
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UPJV-COMP-SLEEP-01
- 2024-10-1/2024-46 (Autre identifiant: Comité d'éthique pour les recherches non interventionnelles (CERNI), Université de Picardie Jules Verne)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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