NCT07083544

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

July 7, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

SleepAthletesActigraphyTrack and fieldSleep hygiene

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).

  • Weekly Training Hours

    Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).

  • Training load

    Ten days before the administration of SHS (T0), and ten days of intervention period (T1, after the administration of SHS).

Study Arms (3)

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

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

Behavioral: Verbal Sleep Hygiene Strategies (V-SHS)

Interventions

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.

W-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.

V-SHS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • any medical condition influencing sleep and the frequency of training in the month preceding the study,
  • training or sleeping in altitude

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences for Health | Università degli Studi di Milano

Milan, Italy

Location

Related Publications (3)

  • 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.

    PMID: 34021090BACKGROUND
  • Walsh 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.

    PMID: 33144349BACKGROUND
  • Vitale 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.

    PMID: 37730209BACKGROUND

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 24, 2025

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

October 17, 2024

Last Updated

July 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations