Clinical trial NCT06945874: Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire
Official title: Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire for Assessing Sleep in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Disorders Not Due to A Substance or Known Physiological Condition
Keywords: sleep disorders in intensive care patients
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of the French translation of the Richards-Campbell questionnaire
timeFrame: Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)
Secondary outcomes:
measure: Inter-rater agreement between patients and nurses
timeFrame: Visit Inclusion (V1, Day 1)
measure: Convergent validity of the results of the French RCSQ with other questionnaires
timeFrame: Visit Inclusion (V1, Day 1)
measure: Convergent validity of the results of the French RCSQ with other questionnaires
timeFrame: Visit Inclusion (V1, Day 1)
measure: Divergent validity of results
timeFrame: Visit Inclusion (V1, Day 1)
measure: French RCSQ's sensitivity to change
timeFrame: Visit V2 (Day 14)
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Rouen
country: France
facility: University Rouen Hospital
Study officials:
affiliation: University Rouen Hospital
name: Marie-Anne MM MELONE, Doctor
role: PRINCIPAL_INVESTIGATOR
References: