NCT03158909

Brief Summary

This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. Half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

May 11, 2017

Last Update Submit

January 10, 2020

Conditions

Delirium

Keywords

EyemaskEarplugs

Outcome Measures

Primary Outcomes (1)

  • Incident cases of delirium.

    The short version of the Confusion Assessment Method (Short-CAM) will be used.

    Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.

Secondary Outcomes (7)

  • Sleep quality

    Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.

  • Safety of the intervention.

    Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.

  • Acceptance, confort and adherence to the intervention.

    After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.

  • Use of psychotropic drugs.

    Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.

  • Time of hospital stay.

    Until hospital discharge, up to 6 months from inclusion in the study.

  • +2 more secondary outcomes

Study Arms (2)

Interventional

EXPERIMENTAL

Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.

Device: Eyemask and earplugsOther: Orientation about space and time

Orientation about space and time

ACTIVE COMPARATOR

This group will receive orientations about space and time olny, every night.

Other: Orientation about space and time

Interventions

Eyemask and earplugsDEVICE

Eyemask and earplugs for use during the night, to improve sleep.

Interventional
Orientation about space and timeOTHER

Information and orientation about space and time, given every night.

InterventionalOrientation about space and time

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In-patients, expected to stay for at least 24 hours.
  • Understand and consent in participating in the study and sign the consent form.
  • years of age, or older.
  • Visual and auditory acuity sufficient to perform cognitive tests.

You may not qualify if:

  • Diagnosis of delirium in the selection visit.
  • Glasgow Coma Scale less than 15 in the selection visit.
  • PRISMA-7 ≤3 patient will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Ear Protective DevicesTime

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and AgriculturePhysical Phenomena

Study Officials

  • Artur S Schuh, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Artur S Schuh, PhD

CONTACT

55 51 3359-8520schuh.afs@gmail.com

Andressa H Hermes-Pereira, Master

CONTACT

55 51 3359-8520andressahpereira@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 18, 2017

Study Start

January 15, 2020

Primary Completion

May 31, 2020

Study Completion

July 30, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

BR(1)