Sleep ExtensionNCT06551935
Effect of Sleep Hygiene and Sleep Extension on Performance in Soccer Players
A study testing Habitual sleep habits without intervention and Sleep extension and sleep hygiene in people with Sleep Extension and Sleep Hygiene, run by University of Maia at 1 site in Portugal.
Trial summary
Sleep is essential for recovery and performance in athletes, yet they often struggle with inadequate sleep duration and quality. Theoretically, strategies such as sleep extension and sleep hygiene could improve sleep and subsequent recovery in athletes, but their effectiveness remains largely unstudied in the… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Extension, Sleep Hygiene, Athletic Performance
- What is being tested?
- Habitual sleep habits without intervention and Sleep extension and sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Aug 2024to 6 Feb 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old
- Sex: Male
- Football players competed in an official competition, organized by the Portuguese Football - Federation (FPF) or regional football associations
Who cannot join
- Players who take sleep medication
- Injured players
- Players with clinical sleep problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sleep Hygiene and Sleep Extension on Performance in Soccer Players: a Randomized Controlled Trial
Sleep is essential for recovery and performance in athletes, yet they often struggle with inadequate sleep duration and quality. Theoretically, strategies such as sleep extension and sleep hygiene could improve sleep and subsequent recovery in athletes, but their effectiveness remains largely unstudied in the literature. This study aimed to analyze the effects of sleep extension and sleep hygiene on physical and cognitive performance in soccer players.
Read the detailed description
Twenty soccer players will be randomized (1:1 ratio) into intervention and control groups. The study will last 4 weeks, divided into two periods: baseline (2 weeks) and intervention (2 weeks). In the baseline period, the players will maintain their normal routine and their sleep habits will be monitored by actigraphy and sleep diaries. The players physical performance will be assessed by the 30-15 intermittent fitness test, countermovement jump, isometric mid-thigh pull and 30-meter sprint, while the cognitive performance will be assessed with the 3-minute psychomotor vigilance test. During the intervention period, the intervention group will extend their usual time in bed by 25% than their baseline period, and adopt sleep hygiene behaviors, while the control group will maintain their usual sleep routine. The physical performance of the players of both groups will be assessed with the same physical tests of the baseline period at the end of week 1 and week 2.
- Conditions
- Sleep Extension, Sleep Hygiene, Athletic Performance
- Being tested
- Habitual sleep habits without intervention, Sleep extension and sleep hygiene
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual sleep habits without interventionBehavioural
Sleep habits maintenance
Sleep extension and sleep hygieneBehavioural
Players will extend their time in bed by 25%, based on their baseline sleep, and adopt sleep hygiene behaviors: relatively fixed sleep schedule; do not lie in bed awake for long periods of time; no caffeine and no alcohol prior to bedtime; avoid heavy meals close to bedtime; sleep environment cool, dark and quiet; low exposure to screen lights before bedtime, only with nightshift mode and low luminosity (avoid high cognitive demanded activities, like gaming); low luminosity near to bedtime; ensure adequate exposure to light in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Without sleep intervention Receives: Behavioral: Habitual sleep habits without intervention |
| Experimental Group | Experimental | Sleep hygiene and sleep extension Receives: Behavioral: Sleep extension and sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Night-time sleep will be monitored each night during the data collection period using wrist-worn actigraphy devices (Actigraph LLC wGT3X-BT, Pensacola, USA). Data will be analyzed using company software (ActiLife LLC Pro software v6.13.3, Pensacola, USA). The sampling frequency will be set to 50 Hz, and the epoch of activity counts 60 s. All sleep variables will be determined using the Sadeh's algorithm
Measured: 4 weeks
30-15 Intermittent Fitness Test
The 30-15 IFT consists of 30-second shuttle runs interspersed with 15-second periods of passive recovery. The initial running speed is set at 8 km/h for the first 30-second run and increased by 0.5 km/h for each subsequent stage. Participants ran back and forth between 2 lines 40 m apart at a pace dictated by a pre-recorded beep. During the 15-s recovery period, each player walked forward to the nearest of the 3 lines (in the middle or at one end of the running area, depending on where the previous leg was completed) in preparation for the next leg. Players were instructed to complete as many legs as possible, and the test ended when a player could no longer maintain the prescribed running speed or was unable to reach a 3-m zone around each line at the time of the audio signal on 3 consecutive occasions. If a player was unable to complete the stage, their score was recorded as the last stage they successfully completed, and their running speed was recorded as their VIFT.
Measured: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Secondary outcomes (4)
30-meters sprint test
The sprint time (seconds) for 15 and 30 m will be recorded using a photocell system (WITTY, Microgate, Bolzano, Italy). Three photocells will be used to assess 15 and 30 m so that both times could be recorded in a single attempt. Subjects will be asked to assume a stationary starting position with the front foot placed 50 cm behind the first cell. Two maximal attempts will be allowed for all tests, with the best result recorded for analysis.
Measured: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Countermovement jump (CMJ)
The CMJ will be recorded with optical detection system (Optogait, Microgate, Bolzano, Italy) and performed with the hands placed on the hips, maintaining the extension of the hip, knee and ankle joints during airtime. Depth during countermovement will be standardized for all players and the average height of three attempts will be recorded.
Measured: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Isometric Mid-thigh pull (IMTP)
The IMTP will be performed using a force platform (ForceDecks, VALD, Brisbane, Australia). Athletes will adopt a standard power-pulling stance, with the bar height set to half the thigh length (50% of the distance between the greater trochanter and lateral epicondyle of the knee). Knee and hip angles will be set to 130-140°. Athletes will perform the IMTP two times at maximal effort. Athletes will be instructed to pull upward on the bar "as quickly and explosively as possible," maintaining maximal effort for two to three seconds.
Measured: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
3-min Psychomotor Vigilance Test (PVT)
The PVT is a standard task used to measure reaction time and has been shown to be sensitive to sleep restriction. The PVT is a 3-minute, iPad-based task (Joggle Research software) requiring athletes to concentrate on a red rectangular box on the screen and tap the screen when a yellow timer appeared in the center of the box. The timer stopped once the participant had responded, indicating the response time in milliseconds. The interstimulus interval varied randomly from 1 to 4 seconds. Responses ≤100ms were labeled "false starts" and responses ≥355 ms were labeled "lapses."
Measured: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start20 Aug 2024
- Primary completion20 Sep 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ExtensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lúcio Cunha, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551935
- Sponsor's protocol ID
- UI/BD/151482/2021
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene and Sleep Extension on Performance in Soccer Players: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06551935
- Acronym / sponsor ID
- UI/BD/151482/2021
- Conditions
- Sleep Extension, Sleep Hygiene, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 13 Aug 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.
Sleep is essential for recovery and performance in athletes, yet they often struggle with inadequate sleep duration and quality. Theoretically, strategies such as sleep extension and sleep hygiene could improve sleep and subsequent recovery in athletes, but their effectiveness remains largely unstudied in the literature. This study aimed to analyze the effects of sleep extension and sleep hygiene on physical and cognitive performance in soccer players.
Detailed description
Twenty soccer players will be randomized (1:1 ratio) into intervention and control groups. The study will last 4 weeks, divided into two periods: baseline (2 weeks) and intervention (2 weeks). In the baseline period, the players will maintain their normal routine and their sleep habits will be monitored by actigraphy and sleep diaries. The players physical performance will be assessed by the 30-15 intermittent fitness test, countermovement jump, isometric mid-thigh pull and 30-meter sprint, while the cognitive performance will be assessed with the 3-minute psychomotor vigilance test. During the intervention period, the intervention group will extend their usual time in bed by 25% than their baseline period, and adopt sleep hygiene behaviors, while the control group will maintain their usual sleep routine. The physical performance of the players of both groups will be assessed with the same physical tests of the baseline period at the end of week 1 and week 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Habitual sleep habits without interventionWithout sleep intervention |
| Experimental Group | Experimental | Behavioral: Sleep extension and sleep hygieneSleep hygiene and sleep extension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥18 years old
- Sex: Male
- Football players competed in an official competition, organized by the Portuguese Football - Federation (FPF) or regional football associations
Key exclusion criteria (3 listed)
- Players who take sleep medication
- Injured players
- Players with clinical sleep problems
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 |
|---|---|---|
| Habitual sleep habits without interventionSleep habits maintenance | Behavioural | Control Group |
| Sleep extension and sleep hygienePlayers will extend their time in bed by 25%, based on their baseline sleep, and adopt sleep hygiene behaviors: relatively fixed sleep schedule; do not lie in bed awake for long periods of time; no caffeine and no alcohol prior to bedtime; avoid heavy meals close to bedtime; sleep environment cool, dark and quiet; low exposure to screen lights before bedtime, only with nightshift mode and low luminosity (avoid high cognitive demanded activities, like gaming); low luminosity near to bedtime; ensure adequate exposure to light in the morning. | Behavioural | Experimental Group |
Primary outcome
Sleep
Time frame: 4 weeks
Night-time sleep will be monitored each night during the data collection period using wrist-worn actigraphy devices (Actigraph LLC wGT3X-BT, Pensacola, USA). Data will be analyzed using company software (ActiLife LLC Pro software v6.13.3, Pensacola, USA). The sampling frequency will be set to 50 Hz, and the epoch of activity counts 60 s. All sleep variables will be determined using the Sadeh's algorithm
30-15 Intermittent Fitness Test
Time frame: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
The 30-15 IFT consists of 30-second shuttle runs interspersed with 15-second periods of passive recovery. The initial running speed is set at 8 km/h for the first 30-second run and increased by 0.5 km/h for each subsequent stage. Participants ran back and forth between 2 lines 40 m apart at a pace dictated by a pre-recorded beep. During the 15-s recovery period, each player walked forward to the nearest of the 3 lines (in the middle or at one end of the running area, depending on where the previous leg was completed) in preparation for the next leg. Players were instructed to complete as many legs as possible, and the test ended when a player could no longer maintain the prescribed running speed or was unable to reach a 3-m zone around each line at the time of the audio signal on 3 consecutive occasions. If a player was unable to complete the stage, their score was recorded as the last stage they successfully completed, and their running speed was recorded as their VIFT.
4 secondary outcomes
30-meters sprint test
Time frame: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Countermovement jump (CMJ)
Time frame: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Isometric Mid-thigh pull (IMTP)
Time frame: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
3-min Psychomotor Vigilance Test (PVT)
Time frame: At the end of the baseline period (2 weeks), after one week of sleep extension and sleep hygiene (intervention period) and after two weeks of sleep extension and sleep hygiene (intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 Habitual sleep habits without intervention and Sleep extension and sleep hygiene in people with Sleep Extension and Sleep Hygiene, run by University of Maia at 1 site in Portugal.
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 3 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep (time frame: 4 weeks). The study lists 2 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 10 Mar 2025.