NCT06251362

Brief Summary

This research aims to investigate the interplay between menstrual cycles, sleep patterns, and athletic performance. Before experimental sessions, participants will maintain menstrual diaries for three months and complete assessments for sleep disorders and chronotype. Sleep duration will be objectively measured over five nights using actigraphy, complemented by sleep-related data from an actigraph and the Karolinska Sleep Diary. The study involves two sessions: normal sleep (based on habitual duration) and restricted sleep (reduced by 3 hours). Athletes will engage in a simulated match-play game before both sessions, followed by comprehensive performance tests the next day. Blood samples will be collected at three intervals to analyze hormonal profiles (including progesterone, and estradiol), markers of muscle damage, inflammation, stress (such as TNF-α, IL-6, CRP, myoglobin, cortisol, testosterone), and brain-derived neurotrophic factor (BDNF). On Day 1, pre- and post-training blood samples will be obtained, and participants will wear an actigraph, adhere to specified bedtime routines, and report activities (restricted sleep group). Day 2 involves completing a sleep diary, refraining from caffeine, responding to questionnaires assessing readiness to train and mood, and undergoing performance tests followed by self-reporting of pain levels and perceived exertion using established scales (VAS, RPE 6-20).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

December 12, 2023

Last Update Submit

April 10, 2024

Conditions

Keywords

acute sleep restrictionearly sleep restrictionfemale athletesfootball

Outcome Measures

Primary Outcomes (6)

  • Countermovement jump

    Vertical jump test performed by having an athlete quickly squat to a self-selected depth and then jump as high as possible.

    1 day after night with or without intervention

  • Sprint test (0-30m)

    1 day after night with or without intervention

  • Zig Zag test

    1 day after night with or without intervention

  • Zig Zag test with ball

    1 day after night with or without intervention

  • Yo-Yo Intermittent endurance test level I

    1 day after night with or without intervention

  • Flanker task

    1 day after night with or without intervention

Secondary Outcomes (5)

  • Mood (POMS)

    1 day after night with or without intervention. During each experimental session. Before sports performance protocol

  • Pain (Pain scale)

    1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions

  • Readiness-to-train questionnaire (RTT-Q)

    1 day after night with or without intervention. During each experimental session. Before sports performance protocol

  • Rating perceived exertion (RPE)

    1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions

  • Stress and recovery (SRSS)

    1 day after night with or without intervention. In the morning, each experimental day and the day after

Other Outcomes (16)

  • Objective Sleep - Total sleep time

    1 day after night with or without intervention. The night before and after the experimental sessions

  • Objective Sleep - Sleep efficiency

    1 day after night with or without intervention. The night before and after the experimental sessions

  • Objective Sleep - WASO (Wake After Sleep Onset)

    1 day after night with or without intervention. The night before and after the experimental sessions

  • +13 more other outcomes

Study Arms (2)

Normal sleep

NO INTERVENTION

The night before the experimental session, where participants will follow their habitual sleep-wake routines.

Sleep restriction

EXPERIMENTAL

The night before the experimental session (with sleep restrictions (SR)), where participants will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep).

Procedure: Sleep restriction

Interventions

Participants will experience a night of acute sleep restriction. During this night, they will sleep 3 hours less than usual.

Sleep restriction

Eligibility Criteria

Age16 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a minimum of 5 years of training experience
  • practicing physical activity for the last 6 months at least 3 times per week for 2h
  • current medical qualification for competitive sport

You may not qualify if:

  • diseases that can have a bad influence on the menstrual cycle (e.g. polycystic ovarian syndrome, endometriosis);
  • using hormonal contraception;
  • regularity of the menstrual cycle.
  • diagnosed cardiovascular, metabolic, gastrointestinal, or neurological diseases; movement, neuromuscular or musculoskeletal disorders;
  • taking medications and supplements that may affect fitness test results; taking supplements that may affect biochemical test results
  • sleep disorders (PSQI \>5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Academy of Physical Education in Krakow

Krakow, 31-571, Poland

COMPLETED

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

February 9, 2024

Study Start

November 25, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-02

Locations