Chronic Insomnia DisorderPRIMONCT06727448
Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health
An observational study of Chronic Insomnia Disorder and Circadian Rhythm Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia Disorder, Circadian Rhythm Disorders
- What is being tested?
- SRQ questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2024to 28 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- SRQ questionnaire
- Keywords
- circadian rhythm disorder, Sleep Regularity Questionnaire, SRQ, chronic insomnia disorder
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRQ questionnaireOther
SRQ questionnaire administered at inclusion visit and 14 days after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Patients | French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders Receives: Other: SRQ questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal validity
consistency measured by Cronbach's alpha and exploratory and confirmatory factor analysis
Measured: At day 14 after inclusion
Secondary outcomes (6)
Insomnia
measured by the Insomnia Severity Index
Measured: at inclusion (day 0)
Sleepiness
measured by the Epworth Sleepiness Scale
Measured: at inclusion (day 0)
Depression and anxiety
measured by the Patient Health Questionnaire-4
Measured: at inclusion (day 0)
Chronotype
measured by the Morningness-Eveningness Scale Short Version
Measured: 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
Measured: at inclusion (day 0) and 14 days after inclusion
Total sleep time
measured by polysomnography
Measured: at inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start23 Dec 2024
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727448
- Sponsor's protocol ID
- CHUBX 2024/13
- Acronym
- PRIMO
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06727448
- Acronym / sponsor ID
- PRIMO / CHUBX 2024/13
- Keywords
- circadian rhythm disorder, Sleep Regularity Questionnaire, SRQ, chronic insomnia disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: SRQ questionnaireFrench patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- French patients indicated for 14-day actimetry for chronic insomnia or circadian rhythm disorders
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRQ questionnaireSRQ questionnaire administered at inclusion visit and 14 days after inclusion | Other | Patients |
Primary outcome
Internal validity
Time frame: At day 14 after inclusion
consistency measured by Cronbach's alpha and exploratory and confirmatory factor analysis
6 secondary outcomes
Insomnia
Time frame: at inclusion (day 0)
Sleepiness
Time frame: at inclusion (day 0)
Depression and anxiety
Time frame: at inclusion (day 0)
Chronotype
Time frame: at inclusion (day 0)
Sleep duration
Time frame: at inclusion (day 0) and 14 days after inclusion
Total sleep time
Time frame: at inclusion (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Insomnia Disorder and Circadian Rhythm Disorders, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal validity (time frame: At day 14 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.