Sleep Disorders Not Due to A Substance or Known Physiological ConditionFrench-RCSQNCT06945874
Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire
An observational study of Sleep Disorders Not Due to A Substance or Known Physiological Condition, run by University Hospital, Rouen at 2 sites in France.
Trial summary
The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders Not Due to A Substance or Known Physiological Condition
- What is being tested?
- Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version
- How many people
- 190 participants
- Where
- 2 sitesFrance
- Study dates
- 12 May 2025to 1 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: The RCSQ-F questionnaire will be distributed at the same time as the ISI and Epworth questionnaires to ICU patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study. The questionnaires will be distributed on two occasions: at the first visit and on the day of discharge from intensive care.
Who may be able to join
- Patient aged ≥ 18 years
- Hospitalised in intensive care for at least 24 hours
- Able to understand and answer questionnaires
- Unsedated (discontinued for 24 hours) presenting a Richmond Sedation Agitation Scale score between ≥-2 and ≤ +1
- Fluent in French
- Having given oral consent for participation in the study
- Person affiliated to a social security scheme.
Who cannot join
- Patient refusal
- Person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship or curatorship)
- Patient unable, for whatever reason, to read, understand or answer the questionnaires (visual problems, psychiatric or cognitive problems, etc.)
- Patient already included in the study or another study evaluating sleep
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Poitiers
Poitiers, 86021
University Rouen Hospital
Rouen, 76031
About this study
Official title: Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire for Assessing Sleep in the Intensive Care Unit
The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.
Read the detailed description
Sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. Consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery.
Current management of these disorders remains limited:
- No pharmacological treatment has clearly demonstrated its efficacy on sleep quality in intensive care.
- Interventions aimed at modulating environmental nuisances (reducing noise, reducing light exposure, respecting day/night cycles) have shown limited effects.
- According to the available data, individual devices (eye masks, earplugs) have not significantly improved sleep architecture.
In this context, the Richards-Campbell questionnaire (RCSQ) represents an interesting alternative for subjectively assessing sleep in intensive care patients. This questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. The validation of a French version of the RCSQ meets a need to standardise assessment practices in France and to gain a better understanding of the factors influencing sleep quality in intensive care.
- Being tested
- Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version
- Keywords
- sleep disorders in intensive care patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french versionDiagnostic test
The RCSQ questionnaire translated into French (RCSQ-F) will be distributed to intensive care patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study.
The questionnaire will be distributed on two occasions: at the first visit and on the day of discharge from intensive care for survivors, or at the latest on the 14th day of hospitalisation.
Patients' use of the questionnaire will enable internal validation (primary objective) by exploratory factor analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the French translation of the Richards-Campbell questionnaire
Assessing the internal validity of the French translation of the Richards-Campbell questionnaire for analysing sleep quality in intensive care patients
Measured: Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)
Secondary outcomes (5)
Inter-rater agreement between patients and nurses
Evaluation of inter-rater agreement between scores given by patients and nurses. The inter-judge agreement between patient and nurse (first secondary objective) will be evaluated by an intra-class correlation coefficient (single measure, absolute agreement, two-way random) on observations with neither missing data on the patient assessment nor the nurse assessment at the V1 visit.
Measured: Visit Inclusion (V1, Day 1)
Convergent validity of the results of the French RCSQ with other questionnaires
To assess the convergent validity of the results of the French RCSQ with the Epworth scale. This convergent validity (2nd secondary objective) will be assessed by the Pearson correlation coefficient of the overall score of the RCSQ-F with the Epworth on observations with no missing data on these scales at the V1 visit.
Measured: Visit Inclusion (V1, Day 1)
Convergent validity of the results of the French RCSQ with other questionnaires
To assess the convergent validity of the results of the French RCSQ with the ISI scale. This convergent validity (2nd secondary objective) will be assessed by the Pearson correlation coefficient of the overall score of the RCSQ-F with the ISI on observations with no missing data on these scales at the V1 visit.
Measured: Visit Inclusion (V1, Day 1)
Divergent validity of results
Assess the divergent validity of the results by analysing the correlation between the French RCSQ and the HAD scale. This divergent validity will be assessed at V1 by calculating the Pearson correlation coefficient between the total RCSQ-F and the HAD scale: a low correlation coefficient (but not necessarily zero) is desirable: R < 0.30 ideally.
Measured: Visit Inclusion (V1, Day 1)
French RCSQ's sensitivity to change
To assess the sensitivity to change of the French RCSQ by analysis of subjects with neither missing data at V1 nor missing data at V2 (discharge from intensive care) concerning the RCSQ-F. Sensitivity to change will be assessed by a 95% Student's confidence interval on paired series estimating the difference in standardised means (i.e. divided by the standard deviation at V1) of the total RCSQ-F. The sensitivity to change of each of the RCSQ-F items will be analysed in the same way. The correlation matrix of changes in the items between V1 and V2 will also be calculated, thus verifying the consistency of the evolutionary trends.
Measured: Visit V2 (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start12 May 2025
- Primary completion8 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders Not Due to A Substance or Known Physiological ConditionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Anne MM MELONE, Doctor, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945874
- Sponsor's protocol ID
- 2025/0017/OB
- Other IDs
- IDRCB : 2025-A00224-45
- Acronym
- French-RCSQ
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire for Assessing Sleep in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06945874
- Acronym / sponsor ID
- French-RCSQ / 2025/0017/OB
- Keywords
- sleep disorders in intensive care patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 25 Apr 2025 (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.
The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.
Detailed description
Sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. Consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery.
Current management of these disorders remains limited:
- No pharmacological treatment has clearly demonstrated its efficacy on sleep quality in intensive care.
- Interventions aimed at modulating environmental nuisances (reducing noise, reducing light exposure, respecting day/night cycles) have shown limited effects.
- According to the available data, individual devices (eye masks, earplugs) have not significantly improved sleep architecture.
In this context, the Richards-Campbell questionnaire (RCSQ) represents an interesting alternative for subjectively assessing sleep in intensive care patients. This questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. The validation of a French version of the RCSQ meets a need to standardise assessment practices in France and to gain a better understanding of the factors influencing sleep quality in intensive care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The RCSQ-F questionnaire will be distributed at the same time as the ISI and Epworth questionnaires to ICU patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study. The questionnaires will be distributed on two occasions: at the first visit and on the day of discharge from intensive care.
Key inclusion criteria (7 listed)
- Patient aged ≥ 18 years
- Hospitalised in intensive care for at least 24 hours
- Able to understand and answer questionnaires
- Unsedated (discontinued for 24 hours) presenting a Richmond Sedation Agitation Scale score between ≥-2 and ≤ +1
- Fluent in French
Key exclusion criteria (4 listed)
- Patient refusal
- Person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship or curatorship)
- Patient unable, for whatever reason, to read, understand or answer the questionnaires (visual problems, psychiatric or cognitive problems, etc.)
- Patient already included in the study or another study evaluating sleep
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 |
|---|---|---|
| Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french versionThe RCSQ questionnaire translated into French (RCSQ-F) will be distributed to intensive care patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study. The questionnaire will be distributed on two occasions: at the first visit and on the day of discharge from intensive care for survivors, or at the latest on the 14th day of hospitalisation. Patients' use of the questionnaire will enable internal validation (primary objective) by exploratory factor analysis. | Diagnostic test | – |
Primary outcome
Validation of the French translation of the Richards-Campbell questionnaire
Time frame: Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)
Assessing the internal validity of the French translation of the Richards-Campbell questionnaire for analysing sleep quality in intensive care patients
5 secondary outcomes
Inter-rater agreement between patients and nurses
Time frame: Visit Inclusion (V1, Day 1)
Convergent validity of the results of the French RCSQ with other questionnaires
Time frame: Visit Inclusion (V1, Day 1)
Convergent validity of the results of the French RCSQ with other questionnaires
Time frame: Visit Inclusion (V1, Day 1)
Divergent validity of results
Time frame: Visit Inclusion (V1, Day 1)
French RCSQ's sensitivity to change
Time frame: Visit V2 (Day 14)
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 17 Jun 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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.
Marie-Anne MM MELONE, Doctor principal investigator
University Rouen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders Not Due to A Substance or Known Physiological Condition, run by University Hospital, Rouen at 2 sites 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 4 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Validation of the French translation of the Richards-Campbell questionnaire (time frame: Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)). 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 17 Jun 2026.