- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06251362
Effects of Sleep Restriction on Female Soccer Players: Physical Performance, Muscle Damage, Inflammation, and BDNF Levels.
The Impact of Sleep Restriction on Physical Performance, Markers of Muscle Damage, Inflammation, and Brain-derived Neurotrophic Factor (BDNF) Levels in Female Soccer Players.
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).
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Msc Radoń
- Phone Number: +48 12 6831142
- Email: anna.radon@awf.krakow.pl
Study Contact Backup
- Name: Zuzanna Msc Komarek
- Phone Number: 791634875
- Email: zuzanna.komarek@doctoral.awf.krakow.pl
Study Locations
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Krakow, Poland, 31-571
- Completed
- The Academy of Physical Education in Krakow
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Kraków, Poland, 31-571
- Recruiting
- University School of Physical Education in Cracow
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Contact:
- Anna Radon
- Phone Number: +48 12 683 12 24
- Email: anna.radon@awf.krakow.pl
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Sub-Investigator:
- Magdalena Więcek, Prof.
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Sub-Investigator:
- Michał Spieszny, Prof.
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Contact:
- Komarek Zuzanna, MSc
- Phone Number: +48603931221
- Email: aleksandra.filip@awf.krakow.pl
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Sub-Investigator:
- Aleksandra Filip-Stachnik, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Normal sleep
The night before the experimental session, where participants will follow their habitual sleep-wake routines.
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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).
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Participants will experience a night of acute sleep restriction.
During this night, they will sleep 3 hours less than usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Countermovement jump
Time Frame: 1 day after night with or without intervention
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Vertical jump test performed by having an athlete quickly squat to a self-selected depth and then jump as high as possible.
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1 day after night with or without intervention
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Sprint test (0-30m)
Time Frame: 1 day after night with or without intervention
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1 day after night with or without intervention
|
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Zig Zag test
Time Frame: 1 day after night with or without intervention
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1 day after night with or without intervention
|
|
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Zig Zag test with ball
Time Frame: 1 day after night with or without intervention
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1 day after night with or without intervention
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Yo-Yo Intermittent endurance test level I
Time Frame: 1 day after night with or without intervention
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1 day after night with or without intervention
|
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Flanker task
Time Frame: 1 day after night with or without intervention
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1 day after night with or without intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood (POMS)
Time Frame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
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The POMS is a widely-applied measure for the assessment of an individual's mood.
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1 day after night with or without intervention. During each experimental session. Before sports performance protocol
|
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Pain (Pain scale)
Time Frame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
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A pain scale is a tool use to help assess a person's pain.
Scale 0 (lack of pain) 10 (maximum pain)
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1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
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Readiness-to-train questionnaire (RTT-Q)
Time Frame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
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Subjective reactions related to the level of motivation for effort
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1 day after night with or without intervention. During each experimental session. Before sports performance protocol
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Rating perceived exertion (RPE)
Time Frame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
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A subjective scale that assesses the severity of effort exerted.
Includes a rating from 6 perceiving "no effort" to 20 perceiving "maximum effort."
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1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
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Stress and recovery (SRSS)
Time Frame: 1 day after night with or without intervention. In the morning, each experimental day and the day after
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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.
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1 day after night with or without intervention. In the morning, each experimental day and the day after
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Sleep - Total sleep time
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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Total sleep time obtained from sleep onset to time at wake-up assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
|
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Objective Sleep - Sleep efficiency
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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The percentage of total sleep time to lights off and leaving bed assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
|
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Objective Sleep - WASO (Wake After Sleep Onset)
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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The total number of minutes that a person is awake after having initially fallen asleep assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
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Objective Sleep - Sleep duration
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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The quantity of time that a person sleeps assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
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Objective Sleep - Sleep onset time
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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The time it takes a person to fall asleep after turning the lights out assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
|
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Objective Sleep - Wake time
Time Frame: 1 day after night with or without intervention. The night before and after the experimental sessions
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The hours in the day that a person is awake assessed by actigraphy
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1 day after night with or without intervention. The night before and after the experimental sessions
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Blood collection - progesterone
Time Frame: 1 day after night with or without intervention. Before each experimental sesion
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Blood will be drawn to measure progesterone
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1 day after night with or without intervention. Before each experimental sesion
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Blood collection - estradiol
Time Frame: 1 day after night with or without intervention. Before each experimental sesion
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Blood will be drawn to measure estradiol
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1 day after night with or without intervention. Before each experimental sesion
|
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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.
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Before and after the match simulation and before the experimental session on the second day 1 day after night with or without intervention.
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
|
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
|
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
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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
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1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
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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
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1 day after night with or without intervention. The morning of the session and the next day after the experimental session
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKN/SP/570683/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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