Clinical trial NCT05078645: Improving Sleep and Reducing External Stimuli With the Maya
Official title: Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of sleep
timeFrame: up to six days
Secondary outcomes:
measure: NRS sleep
timeFrame: up to six days
measure: Anxiety
timeFrame: up to six days
measure: NRS Stress
timeFrame: up to six days
measure: Arousal
timeFrame: up to six days
measure: Delirium CCU
timeFrame: up to six days
measure: Delirium ICU/MC
timeFrame: up to seven days
measure: Light
timeFrame: up to six days
measure: Sound
timeFrame: up to six days
measure: Hart rate
timeFrame: up to six days
measure: Respiratory rate
timeFrame: up to six days
measure: oxygen saturation
timeFrame: up to six days
measure: Blood pressure
timeFrame: up to six days
Other outcomes:
Locations:
Study officials:
affiliation: adboudumc, intensive care, research
name: Bram Tilburgs, Dr.
role: PRINCIPAL_INVESTIGATOR
References: