Critical IllnessNCT05078645
Improving Sleep and Reducing External Stimuli With the Maya
A study testing Maya in people with Critical Illness, run by Radboud University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Maya
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- patients with severe brain damage
- patients with a severe psychiatric disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- Maya
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MayaDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Maya |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to six days
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: up to seven days
Light
Light level (LUX). This will be measured with a validated application on a mobile phone
Measured: up to six days
Sound
Sound levels (decibel). This will be measured with a validated application on a mobile phone
Measured: 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)
Measured: up to six days
Respiratory rate
Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
Measured: up to six days
oxygen saturation
Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
Measured: 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)
Measured: up to six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bram Tilburgs, Radboud University Medical Center
- Investigators
- Bram Tilburgs, Dr., Principal investigator, adboudumc, intensive care, research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078645
- Sponsor's protocol ID
- 2021-13078
- Status last verified
- Oct 2021
- First submitted
- 13 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
- ClinicalTrials.gov ID
- NCT05078645
- Acronym / sponsor ID
- 2021-13078
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Maya use on 1st, 3th and 5th day | Other | Device: MayaGroup 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. |
| Group 2: Maya use on the 2nd, 4th, and 6th day | Other | Device: MayaGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- patients with severe brain damage
- patients with a severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MayaThe 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 | Device | Group 1: Maya use on 1st, 3th and 5th day, Group 2: Maya use on the 2nd, 4th, and 6th day |
Primary outcome
Quality of sleep
Time frame: up to six days
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)
12 secondary outcomes
NRS sleep
Time frame: up to six days
Anxiety
Time frame: up to six days
NRS Stress
Time frame: up to six days
Arousal
Time frame: up to six days
Delirium CCU
Time frame: up to six days
Delirium ICU/MC
Time frame: up to seven days
Light
Time frame: up to six days
Sound
Time frame: up to six days
Hart rate
Time frame: up to six days
Respiratory rate
Time frame: up to six days
oxygen saturation
Time frame: up to six days
Blood pressure
Time frame: up to six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bram Tilburgs, Dr. principal investigator
adboudumc, intensive care, research
Questions about this trial
What is this clinical trial studying?
A study testing Maya in people with Critical Illness, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Tilburgs, Dr. (0031 24 36155618, bram.tilburgs@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep (time frame: up to six days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.