SleepNCT07083544
Sleep Hygiene Strategies Among Track and Field Athletes
A study testing Written Sleep Hygiene Strategies (W-SHS) and Verbal Sleep Hygiene Strategies (V-SHS) in people with Sleep and Athlete, run by University of Milan at 1 site in Italy.
Trial summary
This study aims to evaluate whether different ways of delivering sleep hygiene strategies (SHS)-written materials versus one-on-one verbal instruction-affect sleep behaviors in track and field athletes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Written Sleep Hygiene Strategies (W-SHS) and Verbal Sleep Hygiene Strategies (V-SHS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 17 Oct 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female
- age between 18 and 40 years,
- FIDAL athletes,
- training for any track and field discipline for three or more times per week and over 2.5 hours of training/week.
Who cannot join
- any medical condition influencing sleep and the frequency of training in the month preceding the study,
- training or sleeping in altitude
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences for Health | Università degli Studi di Milano
Milan
About this study
Official title: Comparing the Effectiveness of Sleep Hygiene Strategies Administration in Written vs Verbal Format in Track and Field Athletes: a Randomized Controlled Trial Study.
This study aims to evaluate whether different ways of delivering sleep hygiene strategies (SHS)-written materials versus one-on-one verbal instruction-affect sleep behaviors in track and field athletes. Sleep is essential for athletic recovery and performance, yet many athletes struggle to get enough rest due to both lifestyle and sport-related factors.
Sixty-six athletes were randomly assigned to one of three groups: a control group with no intervention, a group receiving SHS in written form, and a group receiving SHS through a personalized verbal session with a sleep specialist. The intervention lasted 10 consecutive days, and the same strategies were shared with both intervention groups. These strategies included advice on bedtime consistency, reducing screen use before sleep, improving sleep environment, and managing naps.
To monitor changes, participants wore an actigraphy device and completed sleep and training diaries during a 10-day baseline period (before SHS) and again during the 10-day intervention period. Researchers assessed objective sleep parameters like total sleep time, sleep efficiency, and sleep latency, as well as subjective habits using the Sleep Hygiene Index questionnaire.
Read the detailed description
Sleep is vital for athletes, supporting both physical recovery and mental performance. Despite this, many athletes sleep less than recommended due to demanding training schedules, competition stress, travel, and lifestyle factors. Poor sleep impairs recovery, increases injury risk, and reduces athletic performance. One way to address this issue is through Sleep Hygiene Strategies (SHS)-a set of behavioral recommendations that help improve sleep quality and duration.
This randomized controlled trial aims to explore whether the way SHS are delivered-either through written instructions or via verbal education-affects athletes' sleep behaviors and outcomes. The study involves 66 track and field athletes, both male and female, aged 18-40, who train actively at least 2.5 hours per week. Participants are randomly assigned to one of three groups: (1) a control group with no intervention, (2) a group that receives SHS in a written format, or (3) a group that receives SHS via a 40-minute one-on-one verbal session with a trained sleep and sports science professional. The SHS are general and evidence-informed, focusing on optimizing bedtime routines, limiting electronic use before sleep, adjusting environmental factors like noise and temperature, and managing naps effectively.
Each participant has to complete a 10-day baseline sleep monitoring period and a 10-day intervention monitoring period. Sleep is measured using actigraphy (a wrist-worn movement sensor) and self-reported sleep diaries. Additional tools included a training diary and the Sleep Hygiene Index (SHI), a questionnaire is use to assess sleep-related habits.
- Being tested
- Written Sleep Hygiene Strategies (W-SHS), Verbal Sleep Hygiene Strategies (V-SHS)
- Keywords
- Sleep, Athletes, Actigraphy, Track and field, 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.
Written Sleep Hygiene Strategies (W-SHS)Behavioural
Participants assigned to the W-SHS group received a printed handout containing general sleep hygiene strategies. These strategies were designed to improve sleep quality and included recommendations on maintaining a consistent sleep-wake schedule, minimizing light exposure before bedtime, avoiding screens and heavy meals in the evening, optimizing the sleep environment (e.g., room temperature, noise), and managing nap timing. Participants were instructed to apply these strategies consistently for 10 consecutive days. No individual guidance was provided.
Verbal Sleep Hygiene Strategies (V-SHS)Behavioural
Participants in the V-SHS group received the same general sleep hygiene strategies as the W-SHS group, but delivered through a one-on-one verbal education session. A trained researcher in sleep and sport science conducted a 40-minute session with each athlete, explaining each strategy and offering personalized clarifications and suggestions. Participants were then instructed to implement these strategies over a 10-day period.
| Study group | Role | What they receive |
|---|---|---|
| CON | No intervention | Partecipants do not received sleep hygiene in the second timepoint |
| W-SHS | Active comparator | An intervention group following 10 consecutive days of sleep hygiene strategies administered in a written format Receives: Behavioral: Written Sleep Hygiene Strategies (W-SHS) |
| V-SHS | Active comparator | An intervention group following 10 consecutive days of sleep hygiene strategies administered in a verbal format throught an educational session Receives: Behavioral: Verbal Sleep Hygiene Strategies (V-SHS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
This variable is objectively obtained by actigraphy. The total sleep time is the total amount of time a person actually spends sleeping during the night.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Sleep Latency
This variable is objectively obtained by actigraphy. The amount of time it takes to fall asleep after going to bed.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Sleep Efficiency
This variable is objectively obtained by actigraphy. The percentage of time spent asleep while in bed, calculated as TST divided by time in bed.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Wake after sleep onset
This variable is objectively obtained by actigraphy. The total duration of wakefulness occurring after initial sleep onset.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Bedtime
This variable is objectively obtained by actigraphy. The time a person gets into bed with the intention of going to sleep.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Wake up time
This variable is objectively obtained by actigraphy. The time a person finally gets out of bed to start their day.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Sleep regularity index
This variable is objectively obtained by actigraphy. A measure of how consistent sleep and wake times are from day to day.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Secondary outcomes (3)
Number of training
The total count of distinct workouts an athlete completes in a week.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Weekly Training Hours
The cumulative amount of time spent exercising or training over the course of a week.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Training load
A measure that combines the intensity and duration of training to reflect the overall physical demand placed on the body.
Measured: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2023
- Primary completion30 Sep 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Codella, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083544
- Sponsor's protocol ID
- SHS&FIDAL
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sargent C, Lastella M, Halson SL, Roach GD. How Much Sleep Does an Elite Athlete Need? Int J Sports Physiol Perform. 2021 Dec 1;16(12):1746-1757. doi: 10.1123/ijspp.2020-0896. Epub 2021 May 21.
PubMed 34021090Walsh NP, Halson SL, Sargent C, Roach GD, Nedelec M, Gupta L, Leeder J, Fullagar HH, Coutts AJ, Edwards BJ, Pullinger SA, Robertson CM, Burniston JG, Lastella M, Le Meur Y, Hausswirth C, Bender AM, Grandner MA, Samuels CH. Sleep and the athlete: narrative review and 2021 expert consensus recommendations. Br J Sports Med. 2020 Nov 3:bjsports-2020-102025. doi: 10.1136/bjsports-2020-102025. Online ahead of print.
PubMed 33144349Vitale JA, Borghi S, Piacentini MF, Banfi G, La Torre A. To Sleep Dreaming Medals: Sleep Characteristics, Napping Behavior, and Sleep-Hygiene Strategies in Elite Track-and-Field Athletes Facing the Olympic Games of Tokyo 2021. Int J Sports Physiol Perform. 2023 Sep 20;18(12):1412-1419. doi: 10.1123/ijspp.2023-0144. Print 2023 Dec 1.
PubMed 37730209Borghi S, Imperiali L, Vitale J, Codella R, LA Torre A, Tallini E, Sarubbi R, Bizzozero S. Written vs. verbal sleep hygiene strategies administration in track and field athletes: a randomized controlled trial study. J Sports Med Phys Fitness. 2026 Aug 3. doi: 10.23736/S0022-4707.26.17762-7. Online ahead of print.
PubMed 42544425
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Sleep Hygiene Strategies Administration in Written vs Verbal Format in Track and Field Athletes: a Randomized Controlled Trial Study.
- ClinicalTrials.gov ID
- NCT07083544
- Acronym / sponsor ID
- SHS&FIDAL
- Keywords
- Sleep, Athletes, Actigraphy, Track and field, Sleep hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 24 Jul 2025 (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 study aims to evaluate whether different ways of delivering sleep hygiene strategies (SHS)-written materials versus one-on-one verbal instruction-affect sleep behaviors in track and field athletes. Sleep is essential for athletic recovery and performance, yet many athletes struggle to get enough rest due to both lifestyle and sport-related factors.
Sixty-six athletes were randomly assigned to one of three groups: a control group with no intervention, a group receiving SHS in written form, and a group receiving SHS through a personalized verbal session with a sleep specialist. The intervention lasted 10 consecutive days, and the same strategies were shared with both intervention groups. These strategies included advice on bedtime consistency, reducing screen use before sleep, improving sleep environment, and managing naps.
To monitor changes, participants wore an actigraphy device and completed sleep and training diaries during a 10-day baseline period (before SHS) and again during the 10-day intervention period. Researchers assessed objective sleep parameters like total sleep time, sleep efficiency, and sleep latency, as well as subjective habits using the Sleep Hygiene Index questionnaire.
Detailed description
Sleep is vital for athletes, supporting both physical recovery and mental performance. Despite this, many athletes sleep less than recommended due to demanding training schedules, competition stress, travel, and lifestyle factors. Poor sleep impairs recovery, increases injury risk, and reduces athletic performance. One way to address this issue is through Sleep Hygiene Strategies (SHS)-a set of behavioral recommendations that help improve sleep quality and duration.
This randomized controlled trial aims to explore whether the way SHS are delivered-either through written instructions or via verbal education-affects athletes' sleep behaviors and outcomes. The study involves 66 track and field athletes, both male and female, aged 18-40, who train actively at least 2.5 hours per week. Participants are randomly assigned to one of three groups: (1) a control group with no intervention, (2) a group that receives SHS in a written format, or (3) a group that receives SHS via a 40-minute one-on-one verbal session with a trained sleep and sports science professional. The SHS are general and evidence-informed, focusing on optimizing bedtime routines, limiting electronic use before sleep, adjusting environmental factors like noise and temperature, and managing naps effectively.
Each participant has to complete a 10-day baseline sleep monitoring period and a 10-day intervention monitoring period. Sleep is measured using actigraphy (a wrist-worn movement sensor) and self-reported sleep diaries. Additional tools included a training diary and the Sleep Hygiene Index (SHI), a questionnaire is use to assess sleep-related habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CON | No intervention | –Partecipants do not received sleep hygiene in the second timepoint |
| W-SHS | Active comparator | Behavioral: Written Sleep Hygiene Strategies (W-SHS)An intervention group following 10 consecutive days of sleep hygiene strategies administered in a written format |
| V-SHS | Active comparator | Behavioral: Verbal Sleep Hygiene Strategies (V-SHS)An intervention group following 10 consecutive days of sleep hygiene strategies administered in a verbal format throught an educational session |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male or female
- age between 18 and 40 years,
- FIDAL athletes,
- training for any track and field discipline for three or more times per week and over 2.5 hours of training/week.
Key exclusion criteria (2 listed)
- any medical condition influencing sleep and the frequency of training in the month preceding the study,
- training or sleeping in altitude
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 |
|---|---|---|
| Written Sleep Hygiene Strategies (W-SHS)Participants assigned to the W-SHS group received a printed handout containing general sleep hygiene strategies. These strategies were designed to improve sleep quality and included recommendations on maintaining a consistent sleep-wake schedule, minimizing light exposure before bedtime, avoiding screens and heavy meals in the evening, optimizing the sleep environment (e.g., room temperature, noise), and managing nap timing. Participants were instructed to apply these strategies consistently for 10 consecutive days. No individual guidance was provided. | Behavioural | W-SHS |
| Verbal Sleep Hygiene Strategies (V-SHS)Participants in the V-SHS group received the same general sleep hygiene strategies as the W-SHS group, but delivered through a one-on-one verbal education session. A trained researcher in sleep and sport science conducted a 40-minute session with each athlete, explaining each strategy and offering personalized clarifications and suggestions. Participants were then instructed to implement these strategies over a 10-day period. | Behavioural | V-SHS |
Primary outcome
Total sleep time
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The total sleep time is the total amount of time a person actually spends sleeping during the night.
Sleep Latency
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The amount of time it takes to fall asleep after going to bed.
Sleep Efficiency
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The percentage of time spent asleep while in bed, calculated as TST divided by time in bed.
Wake after sleep onset
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The total duration of wakefulness occurring after initial sleep onset.
Bedtime
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The time a person gets into bed with the intention of going to sleep.
Wake up time
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. The time a person finally gets out of bed to start their day.
Sleep regularity index
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
This variable is objectively obtained by actigraphy. A measure of how consistent sleep and wake times are from day to day.
3 secondary outcomes
Number of training
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Weekly Training Hours
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Training load
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
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 24 Jul 2025.
- Background: PubMed 34021090Sargent C, Lastella M, Halson SL, Roach GD. How Much Sleep Does an Elite Athlete Need? Int J Sports Physiol Perform. 2021 Dec 1;16(12):1746-1757. doi: 10.1123/ijspp.2020-0896. Epub 2021 May 21.
- Background: PubMed 33144349Walsh NP, Halson SL, Sargent C, Roach GD, Nedelec M, Gupta L, Leeder J, Fullagar HH, Coutts AJ, Edwards BJ, Pullinger SA, Robertson CM, Burniston JG, Lastella M, Le Meur Y, Hausswirth C, Bender AM, Grandner MA, Samuels CH. Sleep and the athlete: narrative review and 2021 expert consensus recommendations. Br J Sports Med. 2020 Nov 3:bjsports-2020-102025. doi: 10.1136/bjsports-2020-102025. Online ahead of print.
- Background: PubMed 37730209Vitale JA, Borghi S, Piacentini MF, Banfi G, La Torre A. To Sleep Dreaming Medals: Sleep Characteristics, Napping Behavior, and Sleep-Hygiene Strategies in Elite Track-and-Field Athletes Facing the Olympic Games of Tokyo 2021. Int J Sports Physiol Perform. 2023 Sep 20;18(12):1412-1419. doi: 10.1123/ijspp.2023-0144. Print 2023 Dec 1.
- Derived from this study: PubMed 42544425Borghi S, Imperiali L, Vitale J, Codella R, LA Torre A, Tallini E, Sarubbi R, Bizzozero S. Written vs. verbal sleep hygiene strategies administration in track and field athletes: a randomized controlled trial study. J Sports Med Phys Fitness. 2026 Aug 3. doi: 10.23736/S0022-4707.26.17762-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Written Sleep Hygiene Strategies (W-SHS) and Verbal Sleep Hygiene Strategies (V-SHS) in people with Sleep and Athlete, run by University of Milan at 1 site in Italy.
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 4 inclusion and 2 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 24 Jul 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 Italy. 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?
Total sleep time (time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083544, which also lists 4 linked publications.
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 24 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.