Clinical trial NCT06727448: Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health
Official title: Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Insomnia Disorder
Circadian Rhythm Disorders
Keywords: circadian rhythm disorder
Sleep Regularity Questionnaire
SRQ
chronic insomnia disorder
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders

Brief summary: 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.

Detailed description: 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 :

* associations with sleep complaints (insomnia, somnolence),
* mental health complaints (depression, anxiety),
* sleep behaviors and electroencephalographic parameters (sleep architecture, fragmentation).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Internal validity
timeFrame: At day 14 after inclusion
Secondary outcomes:
measure: Insomnia
timeFrame: at inclusion (day 0)
measure: Sleepiness
timeFrame: at inclusion (day 0)
measure: Depression and anxiety
timeFrame: at inclusion (day 0)
measure: Chronotype
timeFrame: at inclusion (day 0)
measure: Sleep duration
timeFrame: at inclusion (day 0) and 14 days after inclusion
measure: Total sleep time
timeFrame: at inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: