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RecruitingNCT06251362Updated Apr 11, 2024

Effects of Sleep Restriction on Female Soccer Players: Physical Performance, Muscle Damage, Inflammation, and BDNF Levels.

An interventional study of Sleep restriction in Sleep and Sleep Restriction, sponsored by University School of Physical Education, Krakow, Poland. Recruiting at 2 sites in Poland. Open to female participants aged 16 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by University School of Physical Education, Krakow, Poland · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
16 Years to 30 Years
Sex
Female
01

Study 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).

Read the detailed description

Before commencing experimental sessions, the menstrual cycles of the participants will be assessed using a menstrual diary spanning three months before the sessions. Additionally, each athlete will be asked to complete a questionnaire for screening sleep disorders (PSQI) and a chronotype classification questionnaire (MEQ). The average sleep duration over five consecutive nights will be measured using actigraphy; this analysis will determine the length of sleep allocated during experimental sessions. Sleep-related parameters will be recorded using an actigraph (MotionWatch8) and confirmed using the Karolinska Sleep Diary (KSD).

The project involves two experimental sessions (each spanning two days) under two different conditions: a) normal sleep (NS; habitual sleep duration determined from the analysis of five consecutive nights) and b) restricted sleep (RS; sleep reduced by 3 hours during the nocturnal period compared to NS). Participants will perform a simulation match-play game (SAFT90) before NS and RS, followed by performance tests on the following day. Blood samples will be collected at three-time points: a) pre-training, b) post-training, and c) before morning tests on the second day of the experiment. Biochemical analysis of the blood will include progesterone and estradiol (for menstrual cycle analysis) as well as parameters related to muscle damage, inflammatory state, and stress levels (TNF-α; IL-6; CRP; myoglobin; hematology; cortisol; testosterone). Additionally, the level of brain-derived neurotrophic factor (BDNF) will be analyzed.

Day 1 of the experiment: Immediately before training, the first blood collection (8 ml) will occur to analyze the necessary blood biochemical parameters. Subsequently, athletes will undergo a standardized afternoon training session, including a simulation match-play game (SAFT90). Another blood sample will be taken immediately after the exercise. Participants will be asked to wear an actigraph on their non-dominant wrist and consume dinner according to the provided recommendations. They will be instructed to go to bed according to a specified schedule (NS or RS). Additionally, participants will be instructed to spend the time before bedtime engaged in routine evening activities (excluding stimulants like coffee or additional exercise). Participants with restricted sleep will also be requested to report their activities every 30 minutes until they go to bed using an internet communicator.

Day 2 of the experiment: Participants will complete the Karolinska Sleep Diary upon waking up. They will also be asked to abstain from consuming caffeine-containing foods and to have breakfast following the provided recommendations. Before the session begins, participants will complete a readiness to train questionnaire (RTQ) and a mood assessment questionnaire (POMS). Blood samples will be collected, followed by specific football-related performance tests: a) repeated high-intensity effort capacity (Yo-Yo test); b) lower limb power (vertical jump); c) maximal acceleration (3x30 m sprints); d) agility with and without the ball (Zig-Zag Test). Immediately after the performance tests, participants will indicate their pain level (Visual Analogue Scale; VAS) and rate their perceived exertion (RPE 6-20).

02

Conditions studied

  • Sleep
  • Sleep Restriction

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Keywords

  • acute sleep restriction
  • early sleep restriction
  • female athletes
  • football
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University School of Physical Education, Krakow, Poland is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • No intervention
    Normal sleep

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

  • Experimental
    Sleep restriction

    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

  • ProcedureSleep restriction

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

06

What researchers measure

Primary outcomes

  1. Countermovement jump

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

    Time frame: 1 day after night with or without intervention

  2. Sprint test (0-30m)

    Time frame: 1 day after night with or without intervention

  3. Zig Zag test

    Time frame: 1 day after night with or without intervention

  4. Zig Zag test with ball

    Time frame: 1 day after night with or without intervention

  5. Yo-Yo Intermittent endurance test level I

    Time frame: 1 day after night with or without intervention

  6. Flanker task

    Time frame: 1 day after night with or without intervention

Secondary outcomes

  1. Mood (POMS)

    The POMS is a widely-applied measure for the assessment of an individual's mood.

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

  2. Pain (Pain scale)

    A pain scale is a tool use to help assess a person's pain. Scale 0 (lack of pain) 10 (maximum pain)

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

  3. Readiness-to-train questionnaire (RTT-Q)

    Subjective reactions related to the level of motivation for effort

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

  4. Rating perceived exertion (RPE)

    A subjective scale that assesses the severity of effort exerted. Includes a rating from 6 perceiving "no effort" to 20 perceiving "maximum effort."

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

  5. Stress and recovery (SRSS)

    The Short Recovery and Stress Scale (SRSS) measure the recovery-stress state of an athlete multidimensionally with eight items on emotional, mental, physical, and overall levels.

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

Other outcomes

  1. Objective Sleep - Total sleep time

    Total sleep time obtained from sleep onset to time at wake-up assessed by actigraphy

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

  2. Objective Sleep - Sleep efficiency

    The percentage of total sleep time to lights off and leaving bed assessed by actigraphy

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

  3. Objective Sleep - WASO (Wake After Sleep Onset)

    The total number of minutes that a person is awake after having initially fallen asleep assessed by actigraphy

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

  4. Objective Sleep - Sleep duration

    The quantity of time that a person sleeps assessed by actigraphy

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

  5. Objective Sleep - Sleep onset time

    The time it takes a person to fall asleep after turning the lights out assessed by actigraphy

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

  6. Objective Sleep - Wake time

    The hours in the day that a person is awake assessed by actigraphy

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

  7. Blood collection - progesterone

    Blood will be drawn to measure progesterone

    Time frame: 1 day after night with or without intervention. Before each experimental sesion

  8. Blood collection - estradiol

    Blood will be drawn to measure estradiol

    Time frame: 1 day after night with or without intervention. Before each experimental sesion

  9. Blood collection - cortisol

    Time frame: Before and after the match simulation and before the experimental session on the second day 1 day after night with or without intervention.

  10. Blood collection - testosterone

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  11. Blood collection - TNF-α

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  12. Blood collection - IL-6

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  13. Blood collection - CRP

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  14. Blood collection - myoglobin

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  15. Blood collection - brain-derived neurotrophic factor (BDNF)

    Time frame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day

  16. Karolinska Sleep Diary (KSD)

    Time frame: 1 day after night with or without intervention. The morning of the session and the next day after the experimental session

07

Study locations

1 of 2 sites recruiting
  • The Academy of Physical Education in Krakow
    Krakow, 31-571, Poland
    Completed
  • University School of Physical Education in Cracow
    Kraków, 31-571, Poland
    • Komarek Zuzanna, MSc · Contact · aleksandra.filip@awf.krakow.pl · +48603931221
    • Anna Radon · Contact · anna.radon@awf.krakow.pl · +48 12 683 12 24
    • Magdalena Więcek, Prof. · Sub investigator
    • Michał Spieszny, Prof. · Sub investigator
    • Aleksandra Filip-Stachnik, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06251362
Lead sponsor
University School of Physical Education, Krakow, Poland
Collaborators
Jagiellonian University
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Nov 25, 2023
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Anna Msc Radoń
Contact
anna.radon@awf.krakow.pl
+48 12 6831142
Zuzanna Msc Komarek
Contact
zuzanna.komarek@doctoral.awf.krakow.pl
791634875

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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