DeliriumNCT03471520
Earplugs and Eye Masks for Reducing Delirium
A study testing Earplugs and eye masks in people with Delirium and Hospital Acquired Condition, run by Duke University at 1 site in United States.
Trial summary
There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Hospital Acquired Condition
- What is being tested?
- Earplugs and eye masks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 8 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
- Age >= 65
Who cannot join
- Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
- Admitted as "observation" (i.e., expected length of stay < 2 nights)
- Admitted > 24 hours prior to time of enrollment
- Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
- Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
- Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available
Show all 14Show fewer
- Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure
- Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)
- Delirium present at time of enrollment
- Glasgow Coma Scale (GCS) < 10 at time of enrollment
- Enrolled in this trial during a previous admission (i.e., we will not resample)
- Enrolled in a separate trial this admission
- Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)
- Significant fall risk per nursing assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.
- Conditions
- Delirium, Hospital Acquired Condition
- Being tested
- Earplugs and eye masks
- Medical subject headings
- Delirium, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earplugs and eye masksBehavioural
Patients in this study will be given earplugs and eye masks to be worn during sleep
| Study group | Role | What they receive |
|---|---|---|
| Earplugs and eye masks | Experimental | Not described Receives: Behavioral: Earplugs and eye masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Will be assessed using the CAM
Measured: The first 5 days of patients' hospitalization
Feasibility as measured by number of patients screened
Measured: 5 days
Feasibility as measured by number of patients ineligible
Measured: 5 days
Feasibility as measured by number of patients who decline to participate
Measured: 5 days
Feasibility as measured by number of patients who dropped out of the study
Measured: 5 days
Feasibility as measured by number of patients who wore the earplugs
Measured: 5 days
Feasibility as measured by number of patients who wore the eye masks
Measured: 5 days
Feasibility as measured by number of CAM assessment days
Measured: 5 days
Feasibility as measured by number of patients who successfully completed the study
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start6 Aug 2018
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliessa Pavon, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471520
- Sponsor's protocol ID
- Pro00087770
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2018
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
- ClinicalTrials.gov ID
- NCT03471520
- Acronym / sponsor ID
- Pro00087770
- Conditions
- Delirium, Hospital Acquired Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 20 Mar 2018 (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.
There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Earplugs and eye masks | Experimental | Behavioral: Earplugs and eye masks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
- Age >= 65
Key exclusion criteria (14 listed)
- Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
- Admitted as "observation" (i.e., expected length of stay < 2 nights)
- Admitted > 24 hours prior to time of enrollment
- Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
- Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
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 |
|---|---|---|
| Earplugs and eye masksPatients in this study will be given earplugs and eye masks to be worn during sleep | Behavioural | Earplugs and eye masks |
Primary outcome
Incidence of delirium
Time frame: The first 5 days of patients' hospitalization
Will be assessed using the CAM
Feasibility as measured by number of patients screened
Time frame: 5 days
Feasibility as measured by number of patients ineligible
Time frame: 5 days
Feasibility as measured by number of patients who decline to participate
Time frame: 5 days
Feasibility as measured by number of patients who dropped out of the study
Time frame: 5 days
Feasibility as measured by number of patients who wore the earplugs
Time frame: 5 days
Feasibility as measured by number of patients who wore the eye masks
Time frame: 5 days
Feasibility as measured by number of CAM assessment days
Time frame: 5 days
Feasibility as measured by number of patients who successfully completed the study
Time frame: 5 days
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 5 Nov 2021.
Related trials for Delirium
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
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.
Juliessa Pavon, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earplugs and eye masks in people with Delirium and Hospital Acquired Condition, run by Duke 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 2 inclusion and 14 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 5 Nov 2021. 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?
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?
Incidence of delirium (time frame: The first 5 days of patients' hospitalization). The study lists 9 primary outcomes in all. 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 5 Nov 2021.