An interventional study of Written Sleep Hygiene Strategies (W-SHS) and Verbal Sleep Hygiene Strategies (V-SHS) in Sleep and Athlete, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
This study's enrollment of 66 is close to the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Browse Sleep Hygiene studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Partecipants do not received sleep hygiene in the second timepoint
An intervention group following 10 consecutive days of sleep hygiene strategies administered in a written format
Behavioral: Written Sleep Hygiene Strategies (W-SHS)
An intervention group following 10 consecutive days of sleep hygiene strategies administered in a verbal format throught an educational session
Behavioral: Verbal Sleep Hygiene Strategies (V-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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Number of training
The total count of distinct workouts an athlete completes in a week.
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
The cumulative amount of time spent exercising or training over the course of a week.
Time frame: 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.
Time frame: Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).
Plan to share: No
Ran from Sep 2023 to primary completion in Sep 2024, 12 months.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 12 months is above that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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