Clinical trial NCT06251362: Effects of Sleep Restriction on Female Soccer Players: Physical Performance, Muscle Damage, Inflammation, and BDNF Levels.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Sleep Restriction
Keywords: acute sleep restriction
early sleep restriction
female athletes
football
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
First posted: 2024-02-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Countermovement jump
timeFrame: 1 day after night with or without intervention
measure: Sprint test (0-30m)
timeFrame: 1 day after night with or without intervention
measure: Zig Zag test
timeFrame: 1 day after night with or without intervention
measure: Zig Zag test with ball
timeFrame: 1 day after night with or without intervention
measure: Yo-Yo Intermittent endurance test level I
timeFrame: 1 day after night with or without intervention
measure: Flanker task
timeFrame: 1 day after night with or without intervention
Secondary outcomes:
measure: Mood (POMS)
timeFrame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
measure: Pain (Pain scale)
timeFrame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
measure: Readiness-to-train questionnaire (RTT-Q)
timeFrame: 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
measure: Rating perceived exertion (RPE)
timeFrame: 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
measure: Stress and recovery (SRSS)
timeFrame: 1 day after night with or without intervention. In the morning, each experimental day and the day after
Other outcomes:
measure: Objective Sleep - Total sleep time
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Objective Sleep - Sleep efficiency
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Objective Sleep - WASO (Wake After Sleep Onset)
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Objective Sleep - Sleep duration
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Objective Sleep - Sleep onset time
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Objective Sleep - Wake time
timeFrame: 1 day after night with or without intervention. The night before and after the experimental sessions
measure: Blood collection - progesterone
timeFrame: 1 day after night with or without intervention. Before each experimental sesion
measure: Blood collection - estradiol
timeFrame: 1 day after night with or without intervention. Before each experimental sesion
measure: Blood collection - cortisol
timeFrame: Before and after the match simulation and before the experimental session on the second day 1 day after night with or without intervention.
measure: Blood collection - testosterone
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Blood collection - TNF-α
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Blood collection - IL-6
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Blood collection - CRP
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Blood collection - myoglobin
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Blood collection - brain-derived neurotrophic factor (BDNF)
timeFrame: 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
measure: Karolinska Sleep Diary (KSD)
timeFrame: 1 day after night with or without intervention. The morning of the session and the next day after the experimental session
Locations:
city: Krakow
country: Poland
facility: The Academy of Physical Education in Krakow
city: Kraków
country: Poland
facility: University School of Physical Education in Cracow
Study officials:
References: