Improving Sleep and Reducing External Stimuli With the Maya

Critical Illness Clinical Trial

Official title:

Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05078645
• Other study ID #: 2021-13078
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Radboud University
• Contact: Bram Tilburgs, Dr.
• Phone: 0031 24 36155618
• Email: bram.tilburgs[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS sleep	Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep)	up to six days
Secondary	Anxiety	Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety)	up to six days
Secondary	NRS Stress	Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress)	up to six days
Secondary	Arousal	patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated)	up to six days
Secondary	Delirium CCU	CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of >= 3 means delirium; maximum score 65)	up to six days
Secondary	Delirium ICU/MC	ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8)	up to seven days
Secondary	Light	Light level (LUX). This will be measured with a validated application on a mobile phone	up to six days
Secondary	Sound	Sound levels (decibel). This will be measured with a validated application on a mobile phone	up to six days
Secondary	Hart rate	hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)	up to six days
Secondary	Respiratory rate	Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute	up to six days
Secondary	oxygen saturation	Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage	up to six days
Secondary	Blood pressure	Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg)	up to six days