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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03773601
Other study ID # Sleep Profiler and athletes
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2018
Est. completion date November 11, 2020

Study information

Verified date November 2020
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sleep is a crucial factor for athletes' health and recovery. Many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. Therefore, the aim of this pilot study is to evalute how sleep quality changes in relation to a late nigth competition in athletes.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 11, 2020
Est. primary completion date November 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - both genders - age between 18 and 45 - sport activity for > or = to 8 hours/week. - signed informed consent Exclusion Criteria: - smoking - part-time or shift worker. - Use of medications able to influence sleep - any medical conditions (injury) contraindicating physical exercise as diagnosed by a sports medicine physician

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sleep Profiler
A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
PSQI
Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
TQR
Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,

Locations

Country Name City State
Italy Jacopo Antonino Vitale Milano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Efficiency Evaluation of the changes in Sleep Efficiency, evaluated by the Sleep Profiler, before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition. From the 1st to the 4th nigth of monitoring
Secondary TQR Evaluation of the changes in the subjective perception of recovery, evaluated with the Total Quality of Recovery Scale (TQR), before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition. From the 1st to the 4th nigth of monitoring
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