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

NCT06727448 | Recruiting

• 1 other identifier: CHUBX 2024/13
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia Disorder; Circadian Rhythm Disorders

Keywords

circadian rhythm disorder; Sleep Regularity Questionnaire; SRQ; chronic insomnia disorder

Outcome Measures

Primary Outcomes (1)

• Internal validity

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

  At day 14 after inclusion

Secondary Outcomes (6)

• 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

Study Arms (1)

Patients

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

Other: SRQ questionnaire

Interventions

SRQ questionnaire OTHER

SRQ questionnaire administered at inclusion visit and 14 days after inclusion

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Julien COELHO, Dr

CONTACT

05 57 82 01 72; Julien.coelho@chu-bordeaux.fr

Cédric VALTAT

CONTACT

05 57 82 01 82; cedric.valtat@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 10, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)