Sleep Quality in Adult ICU PatientsRéa-SLEEPNCT07167485
Sleep Quality of Intensive Care Patients
An observational study of Sleep Quality in Adult ICU Patients, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality in Adult ICU Patients
- What is being tested?
- Assessment of sleep quality
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2022to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care patients
Who may be able to join
- 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)
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Quality of Intensive Care Patients During Their Care Pathway.
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.
Read the detailed description
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.
- Conditions
- Sleep Quality in Adult ICU Patients
- Being tested
- Assessment of sleep quality
- Keywords
- Detoxification and rehabilitation unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sleep qualityOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: At enrollment visit and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start16 Dec 2022
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Quality in Adult ICU PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167485
- Sponsor's protocol ID
- 2020/294/OB
- Other IDs
- 2020-A02632-37
- Acronym
- Réa-SLEEP
- Status last verified
- May 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality of Intensive Care Patients During Their Care Pathway.
- ClinicalTrials.gov ID
- NCT07167485
- Acronym / sponsor ID
- Réa-SLEEP / 2020/294/OB
- Conditions
- Sleep Quality in Adult ICU Patients
- Keywords
- Detoxification and rehabilitation unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care patients
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of sleep qualitySleep 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Compare sleep recovery rates according to hospital unit (intensive care or withdrawal and rehabilitation unit, USR).
Time frame: At enrollment visit and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Quality in Adult ICU Patients, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the quality of sleep in intensive care patients over time (time frame: At enrollment visit and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.