Intensive Care Unit PatientsPhase 3EARSNCT02292134
Improving Sleep Quality in ICU Patients
A Phase 3 study testing earplug and sleep mask in people with Intensive Care Unit Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Patients
- What is being tested?
- earplug and sleep mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Admission in the ICU with expected duration of stay > 48hrs.
- Level of sedation < 4 on Ramsay scale.
- Interruption of sedation > 12 hrs
- Analgesia with a maximal dose of morphine < 0.01 mg/Kg/h
- Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
- Informed consent by patients or next of kind.
Who cannot join
- Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
- Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
- Severe liver encephalopathy (stage 3 or 4)
- Ongoing sepsis
- Pregnancy.
- Age < 18 yrs.
- No health insurance.
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Paris, 75013
About this study
Official title: Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients
Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.
The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.
Read the detailed description
It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delirium, long-term sequels such as post-traumatic stress disorders, alteration of the circadian fluctuation of various hormones with well demonstrated deleterious impact, alteration of the immune response that may promote nosocomial infections and, finally, a decrease of respiratory muscle endurance that may compromise weaning from mechanical ventilation.
Various mechanisms contribute to sleep alteration in ICU patients, including intrinsic factors linked to disease severity, factors related to therapies such as mechanical ventilation and sedation, and environmental factors. Among environmental factors, light and noise are an unavoidable consequence of cares that strongly contribute to sleep alteration in ICU patients. It is of notice that few studies have focused on strategies to protect ICU patients against noise and light such as the systematic use of earplug and sleep mask. Although the benefit of earplug and sleep mask on sleep quality has been demonstrated in healthy subjects submitted to an environment similar to ICU, it has never been evaluated in ICU patients.
The aim of the study is to evaluate the benefit of earplug and sleep mask (designated as "protective strategy) on sleep architecture and quality in ICU patients.
- Conditions
- Intensive Care Unit Patients
- Being tested
- earplug and sleep mask
- Keywords
- Sleep quality, Sleep architecture, Intensive care unit, Light, Noise, Earplug, Sleep mask
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
earplug and sleep maskDevice
Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs
| Study group | Role | What they receive |
|---|---|---|
| earplug and sleep mask | Experimental | Not described Receives: Device: earplug and sleep mask |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sleep stage 3 and 4 (polysomnography)
Significant change of the duration of sleep stage 3 and 4 (polysomnography) in the "protective strategy group" (earplug and sleep mask) as compared to the control group (conventional strategy).
Measured: day 2
Secondary outcomes (8)
Nocturnal awakenings (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Measured: Day 2
Proportion of REM sleep (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Measured: Day 2
Total sleep time (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Measured: Day 2
Sleep time efficiency (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Measured: Day 2
level of anxiety and depression (HAD scale)
participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Measured: At ICU discharge, an expected average of 3 weeks
level of anxiety and depression (HAD scale)
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Measured: At day 90
Incidence of posttraumatic stress disorder syndrome
participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Measured: At ICU discharge, an expected average of 3 weeks
Incidence of posttraumatic stress disorder syndrome
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Measured: At day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292134
- Sponsor's protocol ID
- P081115
- Acronym
- EARS
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.
PubMed 29157258
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients
- ClinicalTrials.gov ID
- NCT02292134
- Acronym / sponsor ID
- EARS / P081115
- Conditions
- Intensive Care Unit Patients
- Keywords
- Sleep quality, Sleep architecture, Intensive care unit, Light, Noise, Earplug, Sleep mask
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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 architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.
The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.
Detailed description
It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delirium, long-term sequels such as post-traumatic stress disorders, alteration of the circadian fluctuation of various hormones with well demonstrated deleterious impact, alteration of the immune response that may promote nosocomial infections and, finally, a decrease of respiratory muscle endurance that may compromise weaning from mechanical ventilation.
Various mechanisms contribute to sleep alteration in ICU patients, including intrinsic factors linked to disease severity, factors related to therapies such as mechanical ventilation and sedation, and environmental factors. Among environmental factors, light and noise are an unavoidable consequence of cares that strongly contribute to sleep alteration in ICU patients. It is of notice that few studies have focused on strategies to protect ICU patients against noise and light such as the systematic use of earplug and sleep mask. Although the benefit of earplug and sleep mask on sleep quality has been demonstrated in healthy subjects submitted to an environment similar to ICU, it has never been evaluated in ICU patients.
The aim of the study is to evaluate the benefit of earplug and sleep mask (designated as "protective strategy) on sleep architecture and quality in ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| earplug and sleep mask | Experimental | Device: earplug and sleep mask |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admission in the ICU with expected duration of stay > 48hrs.
- Level of sedation < 4 on Ramsay scale.
- Interruption of sedation > 12 hrs
- Analgesia with a maximal dose of morphine < 0.01 mg/Kg/h
- Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
Key exclusion criteria (7 listed)
- Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
- Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
- Severe liver encephalopathy (stage 3 or 4)
- Ongoing sepsis
- Pregnancy.
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 |
|---|---|---|
| earplug and sleep maskIndividual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs | Device | earplug and sleep mask |
Primary outcome
Duration of sleep stage 3 and 4 (polysomnography)
Time frame: day 2
Significant change of the duration of sleep stage 3 and 4 (polysomnography) in the "protective strategy group" (earplug and sleep mask) as compared to the control group (conventional strategy).
8 secondary outcomes
Nocturnal awakenings (polysomnography)
Time frame: Day 2
Proportion of REM sleep (polysomnography)
Time frame: Day 2
Total sleep time (polysomnography)
Time frame: Day 2
Sleep time efficiency (polysomnography)
Time frame: Day 2
level of anxiety and depression (HAD scale)
Time frame: At ICU discharge, an expected average of 3 weeks
level of anxiety and depression (HAD scale)
Time frame: At day 90
Incidence of posttraumatic stress disorder syndrome
Time frame: At ICU discharge, an expected average of 3 weeks
Incidence of posttraumatic stress disorder syndrome
Time frame: At day 90
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 17 Nov 2014.
- Derived from this study: PubMed 29157258Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.
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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?
A Phase 3 study testing earplug and sleep mask in people with Intensive Care Unit Patients, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 7 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 17 Nov 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of sleep stage 3 and 4 (polysomnography) (time frame: day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292134, which also lists 1 linked publication.
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 17 Nov 2014.