SleepSleep&Covid19NCT04632615
Sleep Behaviour in Athletes During Home Confinement Due to the Covid-19 Outbreak
An observational study of Sleep and Athlete, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Italian elite athletes will be recruited.
Who may be able to join
- 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).
Who cannot join
- age under 18 years old.
- part-time workers.
- injury or any clinical condition affecting training routines (and sleep).
- pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Motor Activity, COVID-19, Social Isolation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective sleep quality
Subjective sleep quality of athletes will be evaluated by the completion of a survey.
Measured: 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.
Measured: 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.
Measured: This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start22 May 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632615
- Sponsor's protocol ID
- Sleep&Covid19
- Acronym
- Sleep&Covid19
- Status last verified
- Mar 2021
- First submitted
- 12 Nov 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31288293Vitale 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.
PubMed 28493061Vitale 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.
PubMed 25469597Vitale 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.
PubMed 31608830Vitale 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.
PubMed 30760036Pillay 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.
PubMed 32448749Di 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.
PubMed 32513197Hakansson 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.
PubMed 32937978
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Behaviour in Athletes During Home Confinement Due to the Covid-19 Outbreak
- ClinicalTrials.gov ID
- NCT04632615
- Acronym / sponsor ID
- Sleep&Covid19 / Sleep&Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Italian elite athletes will be recruited.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- age under 18 years old.
- part-time workers.
- injury or any clinical condition affecting training routines (and sleep).
- pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Subjective sleep quality
Time frame: This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.
Subjective sleep quality of athletes will be evaluated by the completion of a survey.
Change in Subjective sleep quantity
Time frame: This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.
Subjective sleep quantity of athletes will be evaluated by the completion of a survey.
Change in Training volume
Time frame: This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.
Athletes' weekly training volume will be evaluated by the completion of a survey.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Results publication: PubMed 31288293Vitale 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.
- Results publication: PubMed 28493061Vitale 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.
- Results publication: PubMed 25469597Vitale 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.
- Results publication: PubMed 31608830Vitale 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.
- Results publication: PubMed 30760036Vitale 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.
- Results publication: PubMed 32448749Pillay 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.
- Results publication: PubMed 32513197Di 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.
- Results publication: PubMed 32937978Hakansson 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.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Athlete, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective sleep quality (time frame: This outcome will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632615, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.