- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Avion, Ranska, 62210
- Centre technique et sportif de la Gaillette Gervais Martel
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: Sequence 2: Calf Sleeves - Placebo - Leggings
|
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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Total Sleep Time
Aikaikkuna: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
|
Time in Bed
Aikaikkuna: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
|
Sleep Latency
Aikaikkuna: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
|
Mean Sleep Efficiency Assessed by Wrist Actigraphy
Aikaikkuna: 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.
|
Measured nightly and averaged across the 7 consecutive nights of each condition
|
|
Number of Nocturnal Awakenings
Aikaikkuna: Assessed nightly during each 7-night condition
|
Assessed nightly during each 7-night condition
|
|
|
Subjective Sleep Quality Assessed Using the Sleep Item of the Hooper Questionnaire
Aikaikkuna: 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.
|
Assessed nightly during each 7-night condition
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- UPJV-COMP-SLEEP-01
- 2024-10-1/2024-46 (Muu tunniste: Comité d'éthique pour les recherches non interventionnelles (CERNI), Université de Picardie Jules Verne)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .