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

Primary Purpose

Sleep, Athlete, Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sleep Profiler
PSQI
TQR
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep focused on measuring Sleep, Athlete, Sleep Profiler

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jacopo Antonino Vitale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Athletes

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 11, 2018
Last Updated
November 12, 2020
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT03773601
Brief Title
Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.
Acronym
Sleep Profiler
Official Title
Objective Sleep Behavior in Relation to a Nigth Competition in Athletes: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Athlete, Sleep Deprivation
Keywords
Sleep, Athlete, Sleep Profiler

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Athletes
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Sleep Profiler
Intervention Description
A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
Intervention Type
Other
Intervention Name(s)
PSQI
Intervention Description
Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
Intervention Type
Other
Intervention Name(s)
TQR
Intervention Description
Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
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.
Time Frame
From the 1st to the 4th nigth of monitoring
Secondary Outcome Measure Information:
Title
TQR
Description
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.
Time Frame
From the 1st to the 4th nigth of monitoring

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Jacopo Antonino Vitale
City
Milano
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.

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