Objective Sleep Behavior in Relation to a Nigth Competition in Athletes. (Sleep Profiler)

November 12, 2020 updated by: Istituto Ortopedico Galeazzi

Objective Sleep Behavior in Relation to a Nigth Competition in Athletes: a Pilot Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20161
        • Jacopo Antonino Vitale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Athletes
Athletes will undergo a 4-days sleep monitoring with the use of the Sleep Profler. At the same time, they will fill the Total Quality of Recovery (TQR) scale and the Pittsburgh Sleep Quality Index (PSQI).
Other: Sleep Profiler
A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
Other: PSQI
Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
Other: TQR
Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Efficiency
Time Frame: From the 1st to the 4th nigth of monitoring
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
TQR
Time Frame: From the 1st to the 4th nigth of monitoring
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2018

Primary Completion (ACTUAL)

November 11, 2020

Study Completion (ACTUAL)

November 11, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (ACTUAL)

December 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sleep Profiler and athletes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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