Improving Sleep and Reducing External Stimuli With the Maya

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Device: Maya

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Tilburgs, Dr.; Phone Number: 0031 24 36155618; Email: bram.tilburgs@radboudumc.nl
• Study Contact Backup: Name: Mark van den Boogaard, Dr.; Phone Number: 0031 24 36155618; Email: mark.vandenboogaard@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Light	Light level (LUX). This will be measured with a validated application on a mobile phone	up to six days
Sound	Sound levels (decibel). This will be measured with a validated application on a mobile phone	up to six days
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
Respiratory rate	Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute	up to six days
oxygen saturation	Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage	up to six days
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Bram Tilburgs, Dr., adboudumc, intensive care, research

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2021-13078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No