跳至主要内容
临床试验/NCT07083544
NCT07083544已完成不适用

Comparing the Effectiveness of Sleep Hygiene Strategies Administration in Written vs Verbal Format in Track and Field Athletes: a Randomized Controlled Trial Study.

University of Milan1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Sleep regularity index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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

干预措施: Written Sleep Hygiene Strategies (W-SHS) (Behavioral)

V-SHS

Active Comparator

An intervention group following 10 consecutive days of sleep hygiene strategies administered in a verbal format throught an educational session

干预措施: Verbal Sleep Hygiene Strategies (V-SHS) (Behavioral)

结局指标

主要结局

Sleep regularity index

时间窗: 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.

Wake up time

时间窗: 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 Efficiency

时间窗: 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.

Bedtime

时间窗: 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.

Total sleep time

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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).)
  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Codella

Professor

University of Milan

研究点 (1)

Loading locations...

相似试验