DeliriumNCT01343095
Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
A study testing Foam Earplugs and Noise Canceling Headphones in people with Delirium and Sleep Fragmentation, run by Wake Forest University at 1 site in United States.
Trial summary
This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Sleep Fragmentation
- What is being tested?
- Foam Earplugs and Noise Canceling Headphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients who are admitted to our MICU for at least 24 hours with at least 72 hours' additional expected stay in ICU, and who are mechanically ventilated
Who cannot join
- severe to profound hearing loss
- baseline use of hearing aids
- eardrum perforation
- severe cerumen impaction
- head or oromaxillofacial trauma
- external ventricular drain or intracranial pressure monitoring devices
Show all 9Show fewer
- comatose patients who are deemed by their attending physician as unlikely to awaken within 72 hours
- patient status as comfort-measures only
- any other contraindication to the use of earplugs or headphones
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Controlled Trial of Direct Noise Reduction in the ICU Using Overnight Application of In-ear Earplugs or In-ear Earplugs Plus Noise-Canceling Headphones to Reduce the Incidence and Duration of ICU Delirium
This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.
Read the detailed description
Delirium is an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. Acute delirium is an increasingly recognized problem in intensive care units (ICUs) in the US and worldwide. ICU Delirium has been estimated to occur in as many as 50 to 80 percent of ICU patients. Delirium in the ICU has been associated with worsened clinical outcomes such as prolonged hospitalization and death [1-4]. Although noise has been shown to negatively influence sleep in the ICU, and sleep disturbance is a recognized contributor to ICU delirium[1-2, 4], there is no well-established link between ICU noise levels and the development of ICU delirium. Optimal strategies for the prevention and treatment of ICU delirium are yet to be defined, and this study will focus on a novel noise-reduction approach which has potential to impact both prevention and treatment [5-8]. Findings will be generalizable to other tertiary care medical intensive care units caring for adult patients.
Objectives Our multidisciplinary team will evaluate the safety and feasibility of direct noise reduction in the Wake Forest University Baptist Medical Center (WFUBMC) Medical Intensive Care Unit (MICU), and any effect on the incidence of ICU delirium.
Methods and Measures Design
- Forty-five (45) patients receiving mechanical ventilation will be randomized to receive either passive direct noise reduction (earplugs), both passive and active direct noise reduction (earplugs and noise-canceling headphones), or no direct noise reduction (usual practice).
- Ambient noise levels and the reduction in noise accomplished by direct noise reduction will be measured according to standardized audiometric techniques.
- Sleep structure, including amount of recovery sleep, will be measured over one night according to standardized polysomnographic (sleep study) techniques
- The incidence of delirium will be assessed as well as multiple other endpoints including but not limited to amount of psychoactive medication prescribed and amount of physical restraints required.
- Conditions
- Delirium, Sleep Fragmentation
- Being tested
- Foam Earplugs, Noise Canceling Headphones
- Keywords
- ICU Delirium, Delirium, Sleep Quality, Sleep Efficiency, ICU Noise, Noise Reduction, Earplugs, Noise Canceling Headphones
- Medical subject headings
- Delirium, Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam EarplugsDevice
Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling HeadphonesDevice
Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care between 10pm-6am |
| Earplugs | Active comparator | Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge. Receives: Device: Foam Earplugs |
| Earplugs and Headphones | Active comparator | Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge. Receives: Device: Foam Earplugs; Device: Noise Canceling Headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Free of Delirium or Coma
Measured: During the Study Period (Study Days 0-7 while patients were in ICU)
Secondary outcomes (5)
Noise Attenuation
The reduction in noise experienced by the subject when using the study intervention.
Measured: Overnight (10pm-6am) on study day 2 or 3.
Sleep Efficiency and Architecture
Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.
Measured: Overnight (10pm-6am) on study day 2 or 3
Amount of Sedative Use (Midazolam and Lorazepam)
Measured: During the Study Period (Study Days 0-7)
Amount of Analgesic Use
Mean of analgesic daily use
Measured: During the Study Period (Study Days 0-7)
Amount of Sedative Use (Propofol and Demedetomidine )
Mean of sedative daily use (Propofol and Demedetomidine )
Measured: During the Study Period (Study Days 0-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionJun 2015
Why it stopped: Loss of study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew C Miles, MD, Study director, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343095
- Sponsor's protocol ID
- IRB00013140
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2011
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified data was shared with another investigator as part of a review and meta-analysis
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Direct Noise Reduction in the ICU Using Overnight Application of In-ear Earplugs or In-ear Earplugs Plus Noise-Canceling Headphones to Reduce the Incidence and Duration of ICU Delirium
- ClinicalTrials.gov ID
- NCT01343095
- Acronym / sponsor ID
- IRB00013140
- Conditions
- Delirium, Sleep Fragmentation
- Keywords
- ICU Delirium, Delirium, Sleep Quality, Sleep Efficiency, ICU Noise, Noise Reduction, Earplugs, Noise Canceling Headphones
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of study staff
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 20 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.
Detailed description
Delirium is an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. Acute delirium is an increasingly recognized problem in intensive care units (ICUs) in the US and worldwide. ICU Delirium has been estimated to occur in as many as 50 to 80 percent of ICU patients. Delirium in the ICU has been associated with worsened clinical outcomes such as prolonged hospitalization and death [1-4]. Although noise has been shown to negatively influence sleep in the ICU, and sleep disturbance is a recognized contributor to ICU delirium[1-2, 4], there is no well-established link between ICU noise levels and the development of ICU delirium. Optimal strategies for the prevention and treatment of ICU delirium are yet to be defined, and this study will focus on a novel noise-reduction approach which has potential to impact both prevention and treatment [5-8]. Findings will be generalizable to other tertiary care medical intensive care units caring for adult patients.
Objectives Our multidisciplinary team will evaluate the safety and feasibility of direct noise reduction in the Wake Forest University Baptist Medical Center (WFUBMC) Medical Intensive Care Unit (MICU), and any effect on the incidence of ICU delirium.
Methods and Measures Design
- Forty-five (45) patients receiving mechanical ventilation will be randomized to receive either passive direct noise reduction (earplugs), both passive and active direct noise reduction (earplugs and noise-canceling headphones), or no direct noise reduction (usual practice).
- Ambient noise levels and the reduction in noise accomplished by direct noise reduction will be measured according to standardized audiometric techniques.
- Sleep structure, including amount of recovery sleep, will be measured over one night according to standardized polysomnographic (sleep study) techniques
- The incidence of delirium will be assessed as well as multiple other endpoints including but not limited to amount of psychoactive medication prescribed and amount of physical restraints required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care between 10pm-6am |
| Earplugs | Active comparator | Device: Foam EarplugsApplication of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge. |
| Earplugs and Headphones | Active comparator | Device: Foam Earplugs, Device: Noise Canceling HeadphonesFoam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who are admitted to our MICU for at least 24 hours with at least 72 hours' additional expected stay in ICU, and who are mechanically ventilated
Key exclusion criteria (9 listed)
- severe to profound hearing loss
- baseline use of hearing aids
- eardrum perforation
- severe cerumen impaction
- head or oromaxillofacial trauma
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 |
|---|---|---|
| Foam EarplugsStandard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer) | Device | Earplugs, Earplugs and Headphones |
| Noise Canceling HeadphonesNoise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies. | Device | Earplugs and Headphones |
Primary outcome
Days Free of Delirium or Coma
Time frame: During the Study Period (Study Days 0-7 while patients were in ICU)
5 secondary outcomes
Noise Attenuation
Time frame: Overnight (10pm-6am) on study day 2 or 3.
Sleep Efficiency and Architecture
Time frame: Overnight (10pm-6am) on study day 2 or 3
Amount of Sedative Use (Midazolam and Lorazepam)
Time frame: During the Study Period (Study Days 0-7)
Amount of Analgesic Use
Time frame: During the Study Period (Study Days 0-7)
Amount of Sedative Use (Propofol and Demedetomidine )
Time frame: During the Study Period (Study Days 0-7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. de-identified data was shared with another investigator as part of a review and meta-analysis
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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.
Matthew C Miles, MD study director
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam Earplugs and Noise Canceling Headphones in people with Delirium and Sleep Fragmentation, run by Wake Forest University at 1 site in United States.
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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Sep 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Days Free of Delirium or Coma (time frame: During the Study Period (Study Days 0-7 while patients were in ICU)). 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 12 Sep 2018.