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NCT Number: NCT06727448

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRQ questionnaire

Other

SRQ questionnaire administered at inclusion visit and 14 days after inclusion

Primary outcomes

  1. Internal validity

    Time frame: At day 14 after inclusion

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

Secondary outcomes

  1. Insomnia

    Time frame: at inclusion (day 0)

    measured by the Insomnia Severity Index

  2. Sleepiness

    Time frame: at inclusion (day 0)

    measured by the Epworth Sleepiness Scale

  3. Depression and anxiety

    Time frame: at inclusion (day 0)

    measured by the Patient Health Questionnaire-4

  4. Chronotype

    Time frame: at inclusion (day 0)

    measured by the Morningness-Eveningness Scale Short Version

  5. Sleep duration

    Time frame: at inclusion (day 0) and 14 days after inclusion

    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

  6. Total sleep time

    Time frame: at inclusion (day 0)

    measured by polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

Cédric VALTAT

CONTACT

[email protected]

05 57 82 01 82 ext. +33

Julien COELHO, Dr

CONTACT

[email protected]

05 57 82 01 72 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PRIMO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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