Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire (French-RCSQ)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorders Not Due to A Substance or Known Physiological Condition
• Intervention / Treatment: Diagnostic test: Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version

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 Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: David DM MALLET, Director; Phone Number: +33 02 32 88 82 65; Email: david.mallet@chu-rouen.fr
• Study Contact Backup: Name: Vincent VF FERRANTI, ARC; Phone Number: +33 0232888265; Email: vincent.ferranti@chu-rouen.fr

Study Locations

• France
  • Poitiers, France, 86021
    • University hospital of Poitiers
    • Contact: Xavier XD DROUOT, Professor; Phone Number: +33 05 49 44 34 65; Email: xavier.drouot@chu-poitiers.fr
  • Rouen, France, 76031
    • University Rouen Hospital
    • Contact: Marie-Anne MM MELONE, Doctor; Phone Number: +33 02 32 88 30 23; Email: marieanne.melone@chu-rouen.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Visit V2 (Day 14)

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Marie-Anne MM MELONE, Doctor, University Rouen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sleep disorders in intensive care patients
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Parasomnias; Sleep Wake Disorders
• Other Study ID Numbers: 2025/0017/OB; IDRCB : 2025-A00224-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data provided will be the property of the sponsor and will be used solely for its own research activities.

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