SleepNCT03247062
Sleep Bundle for Improving Sleep in ICU Patients
A study testing Quality improvement - sleep bundle in people with Sleep and Intensive Care Unit Syndrome, run by University Hospital, Geneva.
Trial summary
Summary of the project : Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Sleep, Intensive Care Unit Syndrome
- What is being tested?
- Quality improvement - sleep bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 31 Aug 2018
- Phase
- Interventional
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 yo),
- Hospitalised for ≥ 24h in ICU
- Planned stay of more than 1 day
- After termination of sedation
- Glasgow ≥ 12, SAS ≥ 3-4, CAM-ICU negative
Who cannot join
- patients with neueological disease or neurosurgery requiring neurological assessment every 4hours or more
About this study
Official title: Improving the Quality of Sleep in ICU Patients With a "Sleep Bundle"
Summary of the project :
Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. The patients are then at risk of immune deficiencies, agitation and confusion states, cognitive troubles that may be associated to increased morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU patients may impact non only during the ICU stay but also on their future quality of life.
Read more
The sleep bundle project is a quality improvement project with a before-after design, consisting in the evaluation of a bundle of measures that may increase the quality and duration of sleep in ICU patients.
The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the patients in parallele to structural and organizational modifications of the service such as the decrease of the alarms sounds, changing the luminosity between day and night, etc.
The principal indicators followed will be:
- The sleep quality of the patients
- The continuous noise intensity in the rooms
- The continuous light intensity in the rooms Baseline - before period: 8 weeks Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.
Read the detailed description
Sleep bundle_detailed project _ English
The patients of intensive care unit (ICU) suffer from sleep disorders or lack of sleep due to the particular environment. Among other problems, the noise, the lack of circadian variation of the light lead to a progressive temporal and spatial disorientation. The patients then are subject to a modification of their immunity, present agitation and confusion, neurocognitive disorders with consequences on the morbidity and the short and long-term mortality. An improvement of the sleep of the patients staying in the intensive care will have potentially an impact not only during the stay in the service but also for their future quality of life.
The project " sleep bundle " aims at improving the sleep of the patients by the implementation of a multimodal intervention that consists in a set of measures (or bundle) at different levels: on a structural level in the service), organizational and individual care of the patients.
The intervention, called "sleep bundle" will be proposed to each ICU patient at the bedtime: ear plugs, a mask for eyes, the listening of a soft music, a massage. The whole service structure and organization will be modified by: the installation of a bright light in the daytime and avoidance of light or dark at night, education of the medical and nurse staff in order to increase the awareness of the paitents needs (i.e. limit the light during the night by the use of a shadowless illumination during the night care), a protocol to adapt the volume of the alarms, the implementation of trash cans with shock absorber of lid in every cubicle, the presence of viewable clocks by all the patients (temporal orientation), recalling the necessity of giving to the patients their glasses and hearing aids during daytime.
Design of the project and methodology: this project is a Quality improvement project with the classical BEFORE and AFTER approach. It will measure some quantitative measures and indicators before and after the implementation of the intervention, i.e. the sleep bundle.
Primary objective:
Determine if the sleep of the patients can be improved by the use of one "sleep bundle". The subjective evaluation of the quality of the sleep by the patients will be realized with the "Richard Campbell Sleep Questionnaire (RCSQ)", the analog visual scale, translated into French version, completed by the patient.
The objective evaluation of the depth of the sleep will be realized with the BIS (Index Bispectral), in randomly selected patients according to a table of randomization.
Secondary objectives:
To determine the impact of the implementation of the " sleep bundle " on agitation, delirium, the number of incidents (involuntary removal of naso-gastric tubes, venous lines, endotracheal tubes, etc). The evaluation of the states of agitation and delirium of the patients will be realized via the scores SAS and CAM-ICU.
The following data will be collected in the medical file of patients (SISIF ®):
- Age of the patients, gender, length of ICU stay, history of psychiatric disorders, any dependency (alcohol, benzodiazépines, neuroleptics, tobacco, heroin, methadone, etc).
- Pain scores ( EVA and CPOT), quantity of administered by painkillers, psychotrops, opiates
- Frequency of the care of nursing
- Admission in the room(chamber) during night
- Incidents : involuntary removal of catheters, endotracheal tubes, fall, violence.
The following data will be measured in the environment:
- Luminosity of the cubicle(dock,garage), (the before / later) with a luxmeter
- Monitoring of the noise in the rooms " Soundear Draeger".
The population will consist in:
Inclusion criteria:
- Adults (≥18 years),
- Hospitalized of more than 24 hours in the ICU
- Predictable stay of at least another day
- As soon as the patients is awake, with or without endotracheal tube
- Glasgow ≥12, SAS = 3-4, negative CAM-ICU
Exclusions criteria:
Patients with neurological impairment after medical or surgical insult who require neurological surveillance of more than every 4 hours will not benefit from the sleep bundle.
The sample size was calculated from the average score of RCSQ 49±23 m±DS observed of on 9 experimental patients. We seek to achieve a RCSQ score of ≥65 (with the same DS) in 90 %. 44 patients for the period BEFORE and 44 LATER will be needed. The data of the patients will be collected in a anonymous way.
Every patient holding(retaining) the criteria of inclusion will be included in the project. The estimation practised for the last months before the study period shows that the number of liable patients to be included varies between 5 and 15 patients / week according to the occupation rate of the service.
The duration of 3 periods of the project is going to vary according to the number of patients. By taking into account variations of occupation rate and the possible " drop backs out " according to the clinical evolution of the patient, we plan the next periods:
50 patients during the BEFORE period - duration 8 weeks , 30 patients during the implementation of the bundle-duration 4 weeks, 50 patients AFTER the implementation - duration 8 weeks.
Total duration of the project: 20 weeks.
This project will be sustained in the service thereafter, with a continuous monitoring of the sleep quality of ICU patients (RCSQ ) and some indicators.
- Conditions
- Sleep, Intensive Care Unit Syndrome
- Being tested
- Quality improvement - sleep bundle
- Keywords
- agitation, sleep deprivation, bundle
- Medical subject headings
- Psychomotor Agitation, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement - sleep bundleOther
Also called A sleep bundle to improve the sleep of patients.
implementation of a sleep bundle
| Study group | Role | What they receive |
|---|---|---|
| Cohort study (Before-after desgin) | Other | Quality improvement - sleep bundle Intervention consists in a sleep bundle, an aggregate of several propositions to improve the sleep of patients.: implementation of a sleep bundle.
The entire ICU population will be observed before and after intervention. Receives: Other: Quality improvement - sleep bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ)
Before-after design aiming at increasing the Richards Campbell Sleep Questionnaire (RCSQ) of ICU patients.
Measured: 6 months
Secondary outcomes (3)
agitation episodes
SAS > 6
Measured: 6 months
delirium
CAM ICU +
Measured: 6 months
patient related incident
unvoluntary extubation, cathéters or tube retrieval
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Model description
- Quality improvement project - before after design
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Bara RICOU, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247062
- Sponsor's protocol ID
- ICU Sleep - 01
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Sleep in ICU Patients With a "Sleep Bundle"
- ClinicalTrials.gov ID
- NCT03247062
- Acronym / sponsor ID
- ICU Sleep - 01
- Conditions
- Sleep, Intensive Care Unit Syndrome
- Keywords
- agitation, sleep deprivation, bundle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 11 Aug 2017 (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.
Summary of the project :
Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. The patients are then at risk of immune deficiencies, agitation and confusion states, cognitive troubles that may be associated to increased morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU patients may impact non only during the ICU stay but also on their future quality of life.
The sleep bundle project is a quality improvement project with a before-after design, consisting in the evaluation of a bundle of measures that may increase the quality and duration of sleep in ICU patients.
The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the patients in parallele to structural and organizational modifications of the service such as the decrease of the alarms sounds, changing the luminosity between day and night, etc.
The principal indicators followed will be:
- The sleep quality of the patients
- The continuous noise intensity in the rooms
- The continuous light intensity in the rooms Baseline - before period: 8 weeks Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.
Detailed description
Sleep bundle_detailed project _ English
The patients of intensive care unit (ICU) suffer from sleep disorders or lack of sleep due to the particular environment. Among other problems, the noise, the lack of circadian variation of the light lead to a progressive temporal and spatial disorientation. The patients then are subject to a modification of their immunity, present agitation and confusion, neurocognitive disorders with consequences on the morbidity and the short and long-term mortality. An improvement of the sleep of the patients staying in the intensive care will have potentially an impact not only during the stay in the service but also for their future quality of life.
The project " sleep bundle " aims at improving the sleep of the patients by the implementation of a multimodal intervention that consists in a set of measures (or bundle) at different levels: on a structural level in the service), organizational and individual care of the patients.
The intervention, called "sleep bundle" will be proposed to each ICU patient at the bedtime: ear plugs, a mask for eyes, the listening of a soft music, a massage. The whole service structure and organization will be modified by: the installation of a bright light in the daytime and avoidance of light or dark at night, education of the medical and nurse staff in order to increase the awareness of the paitents needs (i.e. limit the light during the night by the use of a shadowless illumination during the night care), a protocol to adapt the volume of the alarms, the implementation of trash cans with shock absorber of lid in every cubicle, the presence of viewable clocks by all the patients (temporal orientation), recalling the necessity of giving to the patients their glasses and hearing aids during daytime.
Design of the project and methodology: this project is a Quality improvement project with the classical BEFORE and AFTER approach. It will measure some quantitative measures and indicators before and after the implementation of the intervention, i.e. the sleep bundle.
Primary objective:
Determine if the sleep of the patients can be improved by the use of one "sleep bundle". The subjective evaluation of the quality of the sleep by the patients will be realized with the "Richard Campbell Sleep Questionnaire (RCSQ)", the analog visual scale, translated into French version, completed by the patient.
The objective evaluation of the depth of the sleep will be realized with the BIS (Index Bispectral), in randomly selected patients according to a table of randomization.
Secondary objectives:
To determine the impact of the implementation of the " sleep bundle " on agitation, delirium, the number of incidents (involuntary removal of naso-gastric tubes, venous lines, endotracheal tubes, etc). The evaluation of the states of agitation and delirium of the patients will be realized via the scores SAS and CAM-ICU.
The following data will be collected in the medical file of patients (SISIF ®):
- Age of the patients, gender, length of ICU stay, history of psychiatric disorders, any dependency (alcohol, benzodiazépines, neuroleptics, tobacco, heroin, methadone, etc).
- Pain scores ( EVA and CPOT), quantity of administered by painkillers, psychotrops, opiates
- Frequency of the care of nursing
- Admission in the room(chamber) during night
- Incidents : involuntary removal of catheters, endotracheal tubes, fall, violence.
The following data will be measured in the environment:
- Luminosity of the cubicle(dock,garage), (the before / later) with a luxmeter
- Monitoring of the noise in the rooms " Soundear Draeger".
The population will consist in:
Inclusion criteria:
- Adults (≥18 years),
- Hospitalized of more than 24 hours in the ICU
- Predictable stay of at least another day
- As soon as the patients is awake, with or without endotracheal tube
- Glasgow ≥12, SAS = 3-4, negative CAM-ICU
Exclusions criteria:
Patients with neurological impairment after medical or surgical insult who require neurological surveillance of more than every 4 hours will not benefit from the sleep bundle.
The sample size was calculated from the average score of RCSQ 49±23 m±DS observed of on 9 experimental patients. We seek to achieve a RCSQ score of ≥65 (with the same DS) in 90 %. 44 patients for the period BEFORE and 44 LATER will be needed. The data of the patients will be collected in a anonymous way.
Every patient holding(retaining) the criteria of inclusion will be included in the project. The estimation practised for the last months before the study period shows that the number of liable patients to be included varies between 5 and 15 patients / week according to the occupation rate of the service.
The duration of 3 periods of the project is going to vary according to the number of patients. By taking into account variations of occupation rate and the possible " drop backs out " according to the clinical evolution of the patient, we plan the next periods:
50 patients during the BEFORE period - duration 8 weeks , 30 patients during the implementation of the bundle-duration 4 weeks, 50 patients AFTER the implementation - duration 8 weeks.
Total duration of the project: 20 weeks.
This project will be sustained in the service thereafter, with a continuous monitoring of the sleep quality of ICU patients (RCSQ ) and some indicators.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quality improvement project - before after design
| Arm | Type | Receives |
|---|---|---|
| Cohort study (Before-after desgin) | Other | Other: Quality improvement - sleep bundleQuality improvement - sleep bundle Intervention consists in a sleep bundle, an aggregate of several propositions to improve the sleep of patients.: implementation of a sleep bundle. The entire ICU population will be observed before and after intervention. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 yo),
- Hospitalised for ≥ 24h in ICU
- Planned stay of more than 1 day
- After termination of sedation
- Glasgow ≥ 12, SAS ≥ 3-4, CAM-ICU negative
Key exclusion criteria (1 listed)
- patients with neueological disease or neurosurgery requiring neurological assessment every 4hours or more
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 |
|---|---|---|
| Quality improvement - sleep bundleAlso: A sleep bundle to improve the sleep of patients.implementation of a sleep bundle | Other | Cohort study (Before-after desgin) |
Primary outcome
Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ)
Time frame: 6 months
Before-after design aiming at increasing the Richards Campbell Sleep Questionnaire (RCSQ) of ICU patients.
3 secondary outcomes
agitation episodes
Time frame: 6 months
delirium
Time frame: 6 months
patient related incident
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement - sleep bundle in people with Sleep and Intensive Care Unit Syndrome, run by University Hospital, Geneva.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ) (time frame: 6 months). 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 Aug 2017.