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Improving Sleep and Reducing External Stimuli With the Maya

NCT ID: NCT05078645

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-11-30

Brief Summary

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Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs.

Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU.

The Maya is a special "cover" which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy.

With this pilot-study we aim to determine:

* The feasibility and experiences of patients and healthcare professionals with the Maya.
* To determine the effect size of dependent variables which can be used in future studies.

Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Pilot study with a crossover design. Half of the patients will use the Maya on the first, third and fifth day of their admission and will not use the maya on the second fourth and sixth day (group 1). The other half will use the Maya on the second, fourth and sixth day of their admission and will not use the maya on the first, third and fifth day (group 2). Group allocation will be randomised.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1: Maya use on 1st, 3th and 5th day

Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU.

Group Type OTHER

Maya

Intervention Type DEVICE

The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy

Group 2: Maya use on the 2nd, 4th, and 6th day

Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.

Group Type OTHER

Maya

Intervention Type DEVICE

The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy

Interventions

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Maya

The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adult ICU, MC or CCU patients with 5 to 7 expected number of admission days
* patients with an expected Richmond Agitation Sedation Scale (RASS) of \>-3 and \< +3
* patients who speak Dutch (because of the qualitative evaluation of the Maya)

Exclusion Criteria

* patients with severe brain damage
* patients with a severe psychiatric disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bram Tilburgs

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bram Tilburgs, Dr.

Role: PRINCIPAL_INVESTIGATOR

adboudumc, intensive care, research

Central Contacts

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Bram Tilburgs, Dr.

Role: CONTACT

[email protected]
0031 24 36155618

Mark van den Boogaard, Dr.

Role: CONTACT

[email protected]
0031 24 36155618

Other Identifiers

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2021-13078

Identifier Type: -

Identifier Source: org_study_id