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NCT07167485: Réa-SLEEP

Sleep Quality of Intensive Care Patients

Completed Last updated 11 September 2025
What this trial tests

trial testing Assessment of sleep quality in Sleep Quality in Adult ICU Patients in 42 participants. Completed in 6 June 2025.

Timeline
16 December 2022
Primary endpoint
6 June 2025
6 June 2025

Quick facts

Lead sponsorUniversity Hospital, Rouen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment42
Start date16 December 2022
Primary completion6 June 2025
Estimated completion6 June 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Rouen

Who can join

18 and older, any sex, with Sleep Quality in Adult ICU Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep deprivation is common in intensive care. Impaired sleep quality and quantity and altered circadian rhythms have been observed. Polysomnography is the gold standard for sleep analysis. However, it is difficult to perform due to technical constraints and the lack of a consensus definition of the different stages of sleep for intensive care patients. Alternative methods to polysomnography would be useful for better defining sleep disturbances. There are many factors that can disrupt sleep, including environmental disturbances, sedative drugs, mechanical ventilation, and the severity of the condition that led to the patient's admission to intensive care. The consequences of this deprivation include immune system disorders, neuropsychiatric disorders, and impaired functional recovery. Therapeutic management is currently limited, as no drug treatments have been shown to improve sleep quality. Furthermore, no ventilation method has been proven effective in improving sleep. Finally, regulating environmental disturbances-aiming to reduce light exposure, limit noise, and respect day/night rhythms-could improve sleep in intensive care patients. According to recent data, individual measures such as protective eye masks and earplugs have not improved patients' sleep architecture. The aim of our study is therefore to highlight the benefits of the withdrawal and rehabilitation unit (USR) in improving the quality of sleep in intensive care patients. The quality of sleep in intensive care patients in our department will be assessed using a questionnaire validated for intensive care patients, the Richard-Campbell questionnaire (RCSQ). We will also analyse various known risk factors for sleep disturbance in intensive care and USR patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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