CompletedNot Applicable

Sleep Quality of Intensive Care Patients

France42 participantsStarted 2022-12-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessing the quality of sleep in intensive care patients over time

Timeframe: At enrollment visit and Day 14

Trial details

NCT IDNCT07167485

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-06

View on ClinicalTrials.gov More Sleep Quality in Adult ICU Patients trials