Improving Sleep and Reducing External Stimuli With the Maya

Radboud University Medical Center

Status: Unknown

Conditions: Critical Illness

Treatments: Device: Maya

Study type: Interventional

Funder types: Other

Identifiers

NCT05078645

2021-13078

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Other group

Description:

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.

Treatment:

Device: Maya

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

Other group

Description:

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.

Treatment:

Device: Maya