跳至主要内容
临床试验/NCT06727448
NCT06727448已完成不适用

Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月23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
发起方
入组人数
50
试验地点
2
主要终点
Internal validity

研究概览

简要总结

Sleep is an essential function for physical and mental health. The mismatch between biological rhythms and the social rhythms of individuals is increasingly common in modern societies. This sleep irregularity can have numerous consequences on mental health, cardiometabolic health, the immune system, functioning, and quality of life. To address the public health issue of sleep irregularity, it is important to be able to obtain a valid and reliable measure. The Sleep Regularity Questionnaire (SRQ) by Dzierzewski et al. addresses this issue, but has never been translated into French. The aim of the study is to translate and validate the French version of the Sleep Regularity Questionnaire.

详细描述

Sleep is an essential function for physical and mental health. It involves an interaction between homeostatic regulation (need for sleep in the event of deprivation) and circadian regulation (need for sleep according to day-night alternation). Democratized at the end of the 19th century, electric lighting made nocturnal activities possible, and hence the mismatch between individuals' biological and social rhythms (mismatch of rhythms, sleep irregularity, also known as social jetlag). This sleep irregularity is all the more alarming as it is growing epidemically in our societies, and can have numerous consequences on mental health (anxiety, depression), cardiometabolic health (insulin resistance), the immune system (repeated infections), functioning (driving, cognitive performance), and quality of life. To address the public health issue of sleep irregularity, it is important to be able to obtain a valid and reliable measure. The Sleep Regularity Questionnaire (SRQ) by Dzierzewski et al. addresses this health issue, but has never been translated into French.

The investigators make the following assumptions:

  • Cronbach's alpha = 0.87 as in the English version.
  • a two-dimensional structure with a circadian regularity factor and a sleep continuity regularity factor will be confirmed by confirmatory factor analyses.
  • Convergent validity between SRQ results and actimetric measures of sleep regularity (Sleep Regularity Index, intra-individual variability).

The main objective of this study was to translate and validate the French version of the Sleep Regularity Questionnaire (SRQ).

The secondary objectives are to analyze the external validity (convergent and divergent) of the SRQ by calculating :

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥ 18 years of age
  • Patient with indication for 14-day actimetry for chronic insomnia or circadian rhythm disorder
  • Patients with an indication for 14-day actimetry to assess sleep-wake rhythms, for example prior to a 36-hour polysomnographic recording to diagnose central hypersomnia (narcolepsy or idiopathic hypersomnia).
  • Patient affiliated to or benefiting from a social security scheme
  • Patient with French as mother tongue, able to read and write French.
  • Patient able to understand and complete questionnaires independently
  • Patient informed and not opposed to participating in the study

排除标准

  • Current psychiatric disorder (mood disorders, anxiety, psychosis, sleep-interfering use disorder) assessed during interview with investigator
  • Current neurological disorder affecting sleep (neurodegenerative disease, stroke, epilepsy) assessed during interview with investigator
  • Unstable cardiovascular or respiratory diseases
  • Pregnant or breast-feeding women
  • Adults under guardianship or curatorship
  • Opposition to participation expressed by healthy patient/volunteer

研究组 & 干预措施

Patients

French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders

干预措施: SRQ questionnaire (Other)

结局指标

主要结局

Internal validity

时间窗: At day 14 after inclusion

consistency measured by Cronbach's alpha and exploratory and confirmatory factor analysis

次要结局

  • Insomnia(at inclusion (day 0))
  • Sleepiness(at inclusion (day 0))
  • Depression and anxiety(at inclusion (day 0))
  • Chronotype(at inclusion (day 0))
  • Sleep duration(at inclusion (day 0) and 14 days after inclusion)
  • Total sleep time(at inclusion (day 0))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Translation and Validation of the French Version of... | 临床试验