Improving Sleep and Reducing External Stimuli With the Maya

Study Overview
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Maya


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: Maya use on 1st, 3th and 5th day<br>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<br>* 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<br>|
| Other: Group 2: Maya use on the 2nd, 4th, and 6th day<br>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<br>* 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<br>|

What is the study measuring?
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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 |