SleepNCT06251362
Effects of Sleep Restriction on Female Soccer Players: Physical Performance, Muscle Damage, Inflammation, and BDNF Levels.
A study testing Sleep restriction in people with Sleep and Sleep Restriction, run by University School of Physical Education, Krakow, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Restriction
- What is being tested?
- Sleep restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPoland
- Study dates
- 25 Nov 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 1 recruiting
- Completed
The Academy of Physical Education in Krakow
Krakow, 31-571
- Recruiting
University School of Physical Education in Cracow
Krakow, 31-571
Komarek Zuzanna, MSc, +48603931221, aleksandra.filip@awf.krakow.pl
Anna Radon, +48 12 683 12 24, anna.radon@awf.krakow.pl
About this study
Official title: 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).
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).
- Conditions
- Sleep, Sleep Restriction
- Being tested
- Sleep restriction
- Keywords
- acute sleep restriction, early sleep restriction, female athletes, football
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionProcedure or surgery
Participants will experience a night of acute sleep restriction. During this night, they will sleep 3 hours less than usual.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Countermovement jump
Vertical jump test performed by having an athlete quickly squat to a self-selected depth and then jump as high as possible.
Measured: 1 day after night with or without intervention
Sprint test (0-30m)
Measured: 1 day after night with or without intervention
Zig Zag test
Measured: 1 day after night with or without intervention
Zig Zag test with ball
Measured: 1 day after night with or without intervention
Yo-Yo Intermittent endurance test level I
Measured: 1 day after night with or without intervention
Flanker task
Measured: 1 day after night with or without intervention
Secondary outcomes (5)
Mood (POMS)
The POMS is a widely-applied measure for the assessment of an individual's mood.
Measured: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
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)
Measured: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
Readiness-to-train questionnaire (RTT-Q)
Subjective reactions related to the level of motivation for effort
Measured: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
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."
Measured: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
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.
Measured: 1 day after night with or without intervention. In the morning, each experimental day and the day after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start25 Nov 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251362
- Sponsor's protocol ID
- SKN/SP/570683/2023
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleep Restriction on Physical Performance, Markers of Muscle Damage, Inflammation, and Brain-derived Neurotrophic Factor (BDNF) Levels in Female Soccer Players.
- ClinicalTrials.gov ID
- NCT06251362
- Acronym / sponsor ID
- SKN/SP/570683/2023
- Conditions
- Sleep, Sleep Restriction
- Keywords
- acute sleep restriction, early sleep restriction, female athletes, football
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sleep | No intervention | –The night before the experimental session, where participants will follow their habitual sleep-wake routines. |
| Sleep restriction | Experimental | Procedure: Sleep restrictionThe 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). |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep restrictionParticipants will experience a night of acute sleep restriction. During this night, they will sleep 3 hours less than usual. | Procedure or surgery | Sleep restriction |
Primary outcome
Countermovement jump
Time frame: 1 day after night with or without intervention
Vertical jump test performed by having an athlete quickly squat to a self-selected depth and then jump as high as possible.
Sprint test (0-30m)
Time frame: 1 day after night with or without intervention
Zig Zag test
Time frame: 1 day after night with or without intervention
Zig Zag test with ball
Time frame: 1 day after night with or without intervention
Yo-Yo Intermittent endurance test level I
Time frame: 1 day after night with or without intervention
Flanker task
Time frame: 1 day after night with or without intervention
5 secondary outcomes
Mood (POMS)
Time frame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
Pain (Pain scale)
Time frame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
Readiness-to-train questionnaire (RTT-Q)
Time frame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
Rating perceived exertion (RPE)
Time frame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
Stress and recovery (SRSS)
Time frame: 1 day after night with or without intervention. In the morning, each experimental day and the day after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction in people with Sleep and Sleep Restriction, run by University School of Physical Education, Krakow, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Msc Radoń (+48 12 6831142, anna.radon@awf.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Countermovement jump (time frame: 1 day after night with or without intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.