Improving Sleep and Reducing External Stimuli With the Maya

NCT05078645 | Unknown

• 1 other identifier: 2021-13078
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Quality of sleep

  patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)

  up to six days

Secondary Outcomes (12)

• NRS sleep

  up to six days

• Anxiety

  up to six days

• NRS Stress

  up to six days

• Arousal

  up to six days

• Delirium CCU

  up to six days

Study Arms (2)

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

OTHER

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.

Device: Maya

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

OTHER

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.

Device: Maya

Interventions

Maya 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 1: Maya use on 1st, 3th and 5th day; Group 2: Maya use on the 2nd, 4th, and 6th day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• patients with severe brain damage
• patients with a severe psychiatric disorder

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bram Tilburgs, Dr.

  adboudumc, intensive care, research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Tilburgs, Dr.

CONTACT

0031 24 36155618; bram.tilburgs@radboudumc.nl

Mark van den Boogaard, Dr.

CONTACT

0031 24 36155618; mark.vandenboogaard@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 14, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share