Sleep RestrictionNCT06223776
Effects of Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.
A study testing Sleep restriction in people with Sleep Restriction and Sleep, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
The study aims to see how acute sleep restriction will affect women resistance trainers. Above all, the investigators will be interested in observing the relationship between shorter sleep and athletic performance, as well as other important aspects, such as their level of motivation to exercise, how much pain… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Restriction, Sleep
- 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
- 1 sitePoland
- Study dates
- 15 May 2023to 1 Aug 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a minimum of 3 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;
Show all 9Show fewer
- taking supplements that may affect biochemical test results
- sleep disorders
- PSQI >5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of One Night's Acute Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.
The study aims to see how acute sleep restriction will affect women resistance trainers. Above all, the investigators will be interested in observing the relationship between shorter sleep and athletic performance, as well as other important aspects, such as their level of motivation to exercise, how much pain participants felt during exercise and how demanding they found exercise. The investigators assume that differences in subjective measures (such as pain levels, motivation and mood) will be most apparent.
Read the detailed description
Participants would take part in two identical experimental sessions under two sleep conditions:
with sleep restrictions (SR), where will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep); with the control condition (CON), where participants will follow their habitual sleep-wake routines.
Every session would separated by a 1-week interval. The average sleep duration (CON) is going to be estimated by using actigraphy Motionwatch 8 for 5 days (from Monday to Friday).
Female athletes will receive accelerometers one day before experimental sessions. Participants will be asked to wear them on their non-dominant wrists from 8 p.m. to the next morning (experimental sessions day).
The participants would complete the morning session with a battery of physical tests, measuring several components of specific physical performance capacity and cognitive function.
During the experimental sessions, participants would be at the luteal or follicular phases excluding the period of bleeding (4-5 days) and the time immediately before planned bleeding (3 days before), because this can have a bad influence on sleep.
- Conditions
- Sleep Restriction, Sleep
- Being tested
- Sleep restriction
- Keywords
- acute sleep restriction, early sleep restriction
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.
Maximal strength bench press test
The next day after a) sleep restriction b) normal sleep
Measured: 1 day after night with or without intervention
Muscle endurance test in bench press
muscle endurance test in the bench press exercise at 50% 1RM
Measured: 1 day after night with or without intervention
Explosive bench press exercise
three sets of three repetitions of explosive bench press exercise at 50% of the load representing one-repetition maximum (1RM)
Measured: 1 day after night with or without intervention
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
Secondary outcomes (6)
Mood (POMS)
The POMS is a widely-applied measure for the assessment of an individual's mood. During each experimental session. Before sports performance protocol.
Measured: 1 day after night with or without intervention
Pain (Pain scale)
A pain scale is a tool use to help assess a person's pain. Scale 0-10 (0- lack of pain; 10 - maximal pain). Immediately after the last performance exercise in experimental sessions.
Measured: 1 day after night with or without intervention
Motivation
During each experimental session. Before sports performance protocol.
Measured: 1 day after night with or without intervention
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." Immediately after the last performance exercise in experimental sessions.
Measured: 1 day after night with or without intervention
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. In the morning, each experimental day and the day after.
Measured: 1 day after night with or without intervention
Readiness-to-train questionnaire (RTT-Q)
Subjective reactions related to the level of motivation for effort. In the morning, each experimental day and the day after.
Measured: 1 day after night with or without intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 May 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep RestrictionStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223776
- Sponsor's protocol ID
- 160/MN/INoS/2023
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 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
- Effects of One Night's Acute Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.
- ClinicalTrials.gov ID
- NCT06223776
- Acronym / sponsor ID
- 160/MN/INoS/2023
- Conditions
- Sleep Restriction, Sleep
- Keywords
- acute sleep restriction, early sleep restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 25 Jan 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.
The study aims to see how acute sleep restriction will affect women resistance trainers. Above all, the investigators will be interested in observing the relationship between shorter sleep and athletic performance, as well as other important aspects, such as their level of motivation to exercise, how much pain participants felt during exercise and how demanding they found exercise. The investigators assume that differences in subjective measures (such as pain levels, motivation and mood) will be most apparent.
Detailed description
Participants would take part in two identical experimental sessions under two sleep conditions:
with sleep restrictions (SR), where will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep); with the control condition (CON), where participants will follow their habitual sleep-wake routines.
Every session would separated by a 1-week interval. The average sleep duration (CON) is going to be estimated by using actigraphy Motionwatch 8 for 5 days (from Monday to Friday).
Female athletes will receive accelerometers one day before experimental sessions. Participants will be asked to wear them on their non-dominant wrists from 8 p.m. to the next morning (experimental sessions day).
The participants would complete the morning session with a battery of physical tests, measuring several components of specific physical performance capacity and cognitive function.
During the experimental sessions, participants would be at the luteal or follicular phases excluding the period of bleeding (4-5 days) and the time immediately before planned bleeding (3 days before), because this can have a bad influence on sleep.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- 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
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a minimum of 3 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 (9 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;
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
Maximal strength bench press test
Time frame: 1 day after night with or without intervention
The next day after a) sleep restriction b) normal sleep
Muscle endurance test in bench press
Time frame: 1 day after night with or without intervention
muscle endurance test in the bench press exercise at 50% 1RM
Explosive bench press exercise
Time frame: 1 day after night with or without intervention
three sets of three repetitions of explosive bench press exercise at 50% of the load representing one-repetition maximum (1RM)
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.
6 secondary outcomes
Mood (POMS)
Time frame: 1 day after night with or without intervention
Pain (Pain scale)
Time frame: 1 day after night with or without intervention
Motivation
Time frame: 1 day after night with or without intervention
Rating perceived exertion (RPE)
Time frame: 1 day after night with or without intervention
Stress and recovery (SRSS)
Time frame: 1 day after night with or without intervention
Readiness-to-train questionnaire (RTT-Q)
Time frame: 1 day after night with or without intervention
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Restriction and Sleep, run by University School of Physical Education, Krakow, Poland at 1 site 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 9 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal strength bench press test (time frame: 1 day after night with or without intervention). The study lists 4 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.