NCT03773601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

December 11, 2018

Last Update Submit

November 12, 2020

Conditions

Keywords

SleepAthleteSleep Profiler

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • TQR

    From the 1st to the 4th nigth of monitoring

Study Arms (1)

Athletes

EXPERIMENTAL

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 ProfilerOther: PSQIOther: TQR

Interventions

A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.

Athletes
PSQIOTHER

Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.

Athletes
TQROTHER

Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,

Athletes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • both genders
  • age between 18 and 45
  • sport activity for \> or = to 8 hours/week.
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacopo Antonino Vitale

Milan, 20161, Italy

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 12, 2018

Study Start

October 16, 2018

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations