NCT06945874

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 190 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorders Not Due to A Substance or Known Physiological Condition

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

2 sites across 1 country: France