- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Avion, Frankrike, 62210
- Centre technique et sportif de la Gaillette Gervais Martel
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Sequence 1: Leggings - Calf Sleeves - Placebo
|
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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: Sequence 3: Placebo - Leggings - Calf Sleeves
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total Sleep Time
Tidsramme: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
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|
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Time in Bed
Tidsramme: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
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Sleep Latency
Tidsramme: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
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Mean Sleep Efficiency Assessed by Wrist Actigraphy
Tidsramme: Measured nightly and averaged across the 7 consecutive nights of each condition
|
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
Tidsramme: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
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Subjective Sleep Quality Assessed Using the Sleep Item of the Hooper Questionnaire
Tidsramme: Assessed nightly during each 7-night condition
|
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UPJV-COMP-SLEEP-01
- 2024-10-1/2024-46 (Annen identifikator: Comité d'éthique pour les recherches non interventionnelles (CERNI), Université de Picardie Jules Verne)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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