NCT04632615

Brief Summary

It is becoming increasingly evident that sleep plays an essential role for human health, and it represents an important biophysiological variable for athletes' well-being and recovery. The International Olympic Committee recently highlighted the importance of obtaining sufficient sleep volume and quality among athletes, but acute sleep deprivation is not unusual. Several factors, both endogenous and exogenous, are able to negatively influence sleep in athletes: body temperature, altitude, chronotype, training volume, anxiety, westward and eastward travels, and many others. Since December 2019, when a new coronavirus (SARS-CoV-2) was originally revealed by an ophthalmologist in Wuhan (Hubei province, China), a related severe acute respiratory syndrome - namely COVID-19 - has been spreading at a pandemic rate, putting global health systems under unprecedent pressure. Italy, as the first Western country tremendously hit by this disease outbreak, has become the iconic resilient outpost under international policymakers' attention. When initial clusters were identified, restrictive actions to curb isolated upsurges of infection were taken by the health region system of Lombardy, thereafter, were extended to all northern Italy and to the entire country. From February 21, when the first Italian COVID-19 case was diagnosed in southern Lombardy, to March 22, when Italian's government restrictions to contain the pandemic were extended, prohibiting all non-essential business activities and banning all movements of people nationwide, the country faced an unchartered scenario, from several standpoints, along with the psychosocial one. Inevitably, the Covid-19 outbreak has largely influenced the daily life of athletes too. Therefore, the primary aim of this study was to examine the differences in athletes' sleep quality, quantity and training volumes during the social confinement due to the virus outbreak. For this purpose, a survey will be used. This variables will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

November 12, 2020

Last Update Submit

March 3, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Subjective sleep quality

    Subjective sleep quality of athletes will be evaluated by the completion of a survey.

    This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.

  • Change in Subjective sleep quantity

    Subjective sleep quantity of athletes will be evaluated by the completion of a survey.

    This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.

  • Change in Training volume

    Athletes' weekly training volume will be evaluated by the completion of a survey.

    This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Italian elite athletes will be recruited.

You may qualify if:

  • male or female gender.
  • age between 18 and 40 years old.
  • elite athletes (competing at national or international level).
  • no cognitive impairments.
  • at least 6 years of practice of a specific sport discipline.
  • affiliated to CONI (Comitato Olimpico Nazionale Italiano).

You may not qualify if:

  • age under 18 years old.
  • part-time workers.
  • injury or any clinical condition affecting training routines (and sleep).
  • pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Related Publications (8)

  • Vitale KC, Owens R, Hopkins SR, Malhotra A. Sleep Hygiene for Optimizing Recovery in Athletes: Review and Recommendations. Int J Sports Med. 2019 Aug;40(8):535-543. doi: 10.1055/a-0905-3103. Epub 2019 Jul 9.

  • Vitale JA, Weydahl A. Chronotype, Physical Activity, and Sport Performance: A Systematic Review. Sports Med. 2017 Sep;47(9):1859-1868. doi: 10.1007/s40279-017-0741-z.

  • Vitale JA, Roveda E, Montaruli A, Galasso L, Weydahl A, Caumo A, Carandente F. Chronotype influences activity circadian rhythm and sleep: differences in sleep quality between weekdays and weekend. Chronobiol Int. 2015 Apr;32(3):405-15. doi: 10.3109/07420528.2014.986273. Epub 2014 Dec 3.

  • Vitale JA, La Torre A, Banfi G, Bonato M. Acute sleep hygiene strategy improves objective sleep latency following a late-evening soccer-specific training session: A randomized controlled trial. J Sports Sci. 2019 Dec;37(23):2711-2719. doi: 10.1080/02640414.2019.1661938. Epub 2019 Sep 6.

  • Vitale JA, Banfi G, Sias M, La Torre A. Athletes' rest-activity circadian rhythm differs in accordance with the sport discipline. Chronobiol Int. 2019 Apr;36(4):578-586. doi: 10.1080/07420528.2019.1569673. Epub 2019 Feb 14.

  • Pillay L, Janse van Rensburg DCC, Jansen van Rensburg A, Ramagole DA, Holtzhausen L, Dijkstra HP, Cronje T. Nowhere to hide: The significant impact of coronavirus disease 2019 (COVID-19) measures on elite and semi-elite South African athletes. J Sci Med Sport. 2020 Jul;23(7):670-679. doi: 10.1016/j.jsams.2020.05.016. Epub 2020 May 19.

  • Di Renzo L, Gualtieri P, Pivari F, Soldati L, Attina A, Cinelli G, Leggeri C, Caparello G, Barrea L, Scerbo F, Esposito E, De Lorenzo A. Eating habits and lifestyle changes during COVID-19 lockdown: an Italian survey. J Transl Med. 2020 Jun 8;18(1):229. doi: 10.1186/s12967-020-02399-5.

  • Hakansson A, Jonsson C, Kentta G. Psychological Distress and Problem Gambling in Elite Athletes during COVID-19 Restrictions-A Web Survey in Top Leagues of Three Sports during the Pandemic. Int J Environ Res Public Health. 2020 Sep 14;17(18):6693. doi: 10.3390/ijerph17186693.

MeSH Terms

Conditions

Motor ActivityCOVID-19Social Isolation

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 17, 2020

Study Start

May 22, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations