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

U

University Hospital, Rouen

Status

Not yet enrolling

Conditions

Sleep Disorders Not Due to A Substance or Known Physiological Condition

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06945874
IDRCB : 2025-A00224-45 (Other Identifier)
2025/0017/OB

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

2

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Central trial contact

Vincent VF FERRANTI, ARC; David DM MALLET, Director

Data sourced from clinicaltrials.gov

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