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Completed

NCT Number: NCT07167485

Sleep Quality of Intensive Care Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rouen Hospital

Rouen, 76031, France

About this study

The research hypothesis is that the withdrawal and rehabilitation unit, thanks to its spatial organisation, admission policy, management of environmental disturbances and ventilation techniques, could be conducive to better sleep quality.

Patients with prolonged stays (≥14 days) account for between 4 and 11% of admissions to intensive care. By definition, intensive care is a place where patients may experience psychological distress and physical pain. Anxiety and depression, sleep disorders, disruption of the circadian rhythm and sleep debt frequently occur during a stay in intensive care and can hinder the patient's recovery. Measures that are simple in theory, aimed at promoting well-being, are sometimes very difficult to implement in such an acute care setting. Consequently, patients whose stay in intensive care is prolonged, whose clinical condition is stable but who still require 'intensive' care, particularly in relation to mechanical ventilation, muscle weakness and limited autonomy, will require control of these sources of psychological and physical suffering in the hope of promoting their well-being and even improving their rehabilitation. In intensive care, the main sources of discomfort are related to the environment (noise and excessive light) or work organisation, but also to more or less invasive care procedures: procedures associated with ventilation (tracheal suction, extubation), repeated blood sampling, catheter insertion, patient positioning in bed (pain associated with immobilisation, change of position, etc.). Numerous studies report very high noise levels in intensive care units, well above the recommended levels of 45 dB, due to alarms, equipment (ventilators, nebulisers, etc.), the behaviour of paramedical staff, and also medical staff (peaks during visits). An interesting alternative may then be to transfer the patient to a specific unit, either for weaning and rehabilitation or for continuous post-resuscitation care.

In Rouen, for example, there is a respiratory weaning and rehabilitation unit with specialised nursing staff in an environment considered more conducive to weaning and rehabilitation (specific paramedical team, daytime activities, no night-time admissions, corridor lights turned off at night, reasoned monitoring of vital signs). This unit could also be conducive to better control of environmental disturbances to ensure normal circadian rhythms and sufficient quantity and quality of sleep.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • over 18 years of age
  • clinically stable (no amines or sedation for more than 48 hours)
  • hospitalised for more than 7 days in intensive care
  • conscious
  • with no central neurological pathology
  • with no major cognitive impairment
  • with no sleep disorder (OSA, insomnia, restless legs syndrome)

Exclusion criteria

Age < 18 years old Patient refusal Person deprived of liberty by administrative or judicial decision or protected adult (under guardianship or trusteeship); Patient unable, for whatever reason, to read, understand or answer questionnaires (visual impairment, psychiatric or cognitive disorders, etc.).

Treatment and study plan

Assessment of sleep quality

Other

Sleep quality will be assessed each night in intensive care using a Richards-Campbell sleep questionnaire and an intensive care sleep questionnaire, completed by the patient.

Primary outcomes

  1. Assessing the quality of sleep in intensive care patients over time

    Time frame: At enrollment visit and Day 14

    Sleep quality according to the Richard-Campbell questionnaire (RCSQ) score. The Richards Campbell Sleep Questionnaire is a widely used sleep quality instrument comprising visual analogue scales (VAS) 0-100 mm allowing assessment of sleep depth, falling asleep, number of awakenings, percent of time awake, and overall quality of sleep domains. The higher the score, the better the quality of sleep.

Secondary outcomes

  1. Compare sleep recovery rates according to hospital unit (intensive care or withdrawal and rehabilitation unit, USR).

    Time frame: At enrollment visit and Day 14

    The intensive care sleep questionnaire is a tool used to assess sleep quality. It includes visual analogue scales (VAS) from 0 to 100 mm that allow the depth of sleep, the time taken to fall asleep, the number of times the patient wakes up, the percentage of time spent awake and the overall quality of sleep to be assessed. It includes visual analogue scales (VAS) from 0 to 4 mm that assess difficulty falling asleep and difficulty staying asleep. The higher the score, the better the sleep quality.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Sleep Quality of Intensive Care Patients During Their Care Pathway.

Acronym: Réa-SLEEP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

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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