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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06251362
Other study ID # SKN/SP/570683/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 25, 2023
Est. completion date June 2024

Study information

Verified date February 2024
Source University School of Physical Education, Krakow, Poland
Contact Anna Msc Radon
Phone +48 12 6831142
Email anna.radon@awf.krakow.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland The Academy of Physical Education in Krakow Krakow
Poland University School of Physical Education in Cracow Kraków

Sponsors (2)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Objective Sleep - Total sleep time Total sleep time obtained from sleep onset to time at wake-up assessed by actigraphy 1 day after night with or without intervention. The night before and after the experimental sessions
Other Objective Sleep - Sleep efficiency The percentage of total sleep time to lights off and leaving bed assessed by actigraphy 1 day after night with or without intervention. The night before and after the experimental sessions
Other 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 1 day after night with or without intervention. The night before and after the experimental sessions
Other Objective Sleep - Sleep duration The quantity of time that a person sleeps assessed by actigraphy 1 day after night with or without intervention. The night before and after the experimental sessions
Other Objective Sleep - Sleep onset time The time it takes a person to fall asleep after turning the lights out assessed by actigraphy 1 day after night with or without intervention. The night before and after the experimental sessions
Other Objective Sleep - Wake time The hours in the day that a person is awake assessed by actigraphy 1 day after night with or without intervention. The night before and after the experimental sessions
Other Blood collection - progesterone Blood will be drawn to measure progesterone 1 day after night with or without intervention. Before each experimental sesion
Other Blood collection - estradiol Blood will be drawn to measure estradiol 1 day after night with or without intervention. Before each experimental sesion
Other Blood collection - cortisol Before and after the match simulation and before the experimental session on the second day 1 day after night with or without intervention.
Other Blood collection - testosterone 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Blood collection - TNF-a 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Blood collection - IL-6 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Blood collection - CRP 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Blood collection - myoglobin 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Blood collection - brain-derived neurotrophic factor (BDNF) 1 day after night with or without intervention. Before and after the match simulation and before the experimental session on the second day
Other Karolinska Sleep Diary (KSD) 1 day after night with or without intervention. The morning of the session and the next day after the experimental session
Primary 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
Primary Sprint test (0-30m) 1 day after night with or without intervention
Primary Zig Zag test 1 day after night with or without intervention
Primary Zig Zag test with ball 1 day after night with or without intervention
Primary Yo-Yo Intermittent endurance test level I 1 day after night with or without intervention
Primary Flanker task 1 day after night with or without intervention
Secondary Mood (POMS) The POMS is a widely-applied measure for the assessment of an individual's mood. 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
Secondary 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) 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
Secondary Readiness-to-train questionnaire (RTT-Q) Subjective reactions related to the level of motivation for effort 1 day after night with or without intervention. During each experimental session. Before sports performance protocol
Secondary 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." 1 day after night with or without intervention. Immediately after the last performance exercise in experimental sessions
Secondary 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. 1 day after night with or without intervention. In the morning, each experimental day and the day after
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