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

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.

Study Overview

• Status: Recruiting
• Conditions: Circadian Rhythm Disorders; Chronic Insomnia Disorder
• Intervention / Treatment: Other: SRQ 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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Julien COELHO, Dr; Phone Number: +33 05 57 82 01 72; Email: Julien.coelho@chu-bordeaux.fr
• Study Contact Backup: Name: Cédric VALTAT; Phone Number: +33 05 57 82 01 82; Email: cedric.valtat@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Chu de Bordeaux
    • Contact: Julien COELHO, Dr; Phone Number: +33 05 57 82 01 72; Email: Julien.coelho@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders	Other: SRQ questionnaire; SRQ questionnaire administered at inclusion visit and 14 days after inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal validity	consistency measured by Cronbach's alpha and exploratory and confirmatory factor analysis	At day 14 after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia	measured by the Insomnia Severity Index	at inclusion (day 0)
Sleepiness	measured by the Epworth Sleepiness Scale	at inclusion (day 0)
Depression and anxiety	measured by the Patient Health Questionnaire-4	at inclusion (day 0)
Chronotype	measured by the Morningness-Eveningness Scale Short Version	at inclusion (day 0)
Sleep duration	measured by actimetry : this examination is used to determine the presence or absence of circadian rhythm disorders and to assess sleep duration s It is the reference examination	at inclusion (day 0) and 14 days after inclusion
Total sleep time	measured by polysomnography	at inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: chronic insomnia disorder; circadian rhythm disorder; Sleep Regularity Questionnaire; SRQ
• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders
• Other Study ID Numbers: CHUBX 2024/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No