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NCT Number: NCT06945874

Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire

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.

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Key information

Conditions

Sleep Disorders Not Due to A Substance or Known Physiological Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Poitiers, Poitiers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version

Diagnostic 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Inter-rater agreement between patients and nurses

    Time frame: Visit Inclusion (V1, Day 1)

    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.

  2. Convergent validity of the results of the French RCSQ with other questionnaires

    Time frame: Visit Inclusion (V1, Day 1)

    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.

  3. Convergent validity of the results of the French RCSQ with other questionnaires

    Time frame: Visit Inclusion (V1, Day 1)

    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.

  4. Divergent validity of results

    Time frame: Visit Inclusion (V1, Day 1)

    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.

  5. French RCSQ's sensitivity to change

    Time frame: Visit V2 (Day 14)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire for Assessing Sleep in the Intensive Care Unit

Acronym: French-RCSQ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Jun 17, 2026

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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