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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04632615
Other study ID # Sleep&Covid19
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 22, 2020
Est. completion date March 31, 2021

Study information

Verified date March 2021
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - age under 18 years old. - part-time workers. - injury or any clinical condition affecting training routines (and sleep). - pregnant women.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Di Renzo L, Gualtieri P, Pivari F, Soldati L, Attinà 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. d — View Citation

Håkansson A, Jönsson C, Kenttä 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). pii: E6693. — View Citation

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 S — View Citation

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. — View Citation

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: 10.1080/0264041 — View Citation

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: 10.3109/074205 — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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