Sleep Quality of Intensive Care Patients

NCT07167485 | Completed

• 2 other identifiers: 2020/294/OB2020-A02632-37
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Quality in Adult ICU Patients

Keywords

Detoxification and rehabilitation unit

Outcome Measures

Primary Outcomes (1)

• Assessing the quality of sleep in intensive care patients over time

  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.

  At enrollment visit and Day 14

Secondary Outcomes (1)

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

  At enrollment visit and Day 14

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

intensive care patients

You may qualify if:

• 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)

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: December 16, 2022
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)