Delirium in the Intensive Care UnitDECIBELNCT07364097
A Study of Silent Alarm Delivery Versus Standard Audible Alarm Delivery in Intensive Care and High Dependency Units
A study testing Silent alarm strategy in people with Delirium in the Intensive Care Unit and Burnout, Healthcare Workers, run by MindWave Medical Inc at 1 site in India.
Trial summary
The goal of the trial is to learn if a strategy to eliminate audible alarm noise in intensive care and high dependency units can reduce overall noise levels, patient delirium, staff alarm fatigue, and staff burnout. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium in the Intensive Care Unit, Burnout, Healthcare Workers, Noise in the ICU
- What is being tested?
- Silent alarm strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteIndia
- Study dates
- 3 Feb 2026to 18 Apr 2026
- 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
- Admission to Intensive or high dependency care unit.
Who cannot join
- Pre-existing diagnosis of dementia
- Endotracheally intubated (may enroll when extubated)
- CNS injury, infection, or malignancy as reason for admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Eliminating Alarm Noise Cacophony for Intensive Care Staff and Patients Improve Burnout and Encephalopathy Levels
The goal of the trial is to learn if a strategy to eliminate audible alarm noise in intensive care and high dependency units can reduce overall noise levels, patient delirium, staff alarm fatigue, and staff burnout. Researchers will implement a silent alarm strategy in specific care units for four weeks and compare this to a separate 4 weeks where a silent strategy is not implemented. Noise, burnout, delirium levels, and staff alarm response times will be compared between the silent and non-silent units.
- Conditions
- Delirium in the Intensive Care Unit, Burnout, Healthcare Workers, Noise in the ICU, Alarm Fatigue, Alarm Fatigue in Intensive Care Unit Nurses, Alarms
- Being tested
- Silent alarm strategy
- Keywords
- ICU delirium, alarm fatigue, silent alarm, alarm noise, nursing burnout, nursing work, alarm response
- Medical subject headings
- Burnout, Psychological, Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silent alarm strategyOther
The intervention consists of the implementation of a silent alarm system in the clinical environment. The silent alarm system consists of a self-locating interface device, which is interposed between an alarm-generating device and its audio output. This device contains communication, locating, motion, logic, and relay chips, which enable the interface device to identify its location and staff responsible for that location, as well as to detect audio output from the alarm-generating device, and to control the audible state of that output. The Interface device can communicate with separate bone conduction headsets worn by staff, which contain sensors that confirm staff presence at the headset, and buttons for response to an alarm announcement. The interface device then delivers alarms silently to those staff specifically responsible for its location when a responsible staff member can be identified, confirmed to be present, and accepts responsibility for the alarm through button action.
| Study group | Role | What they receive |
|---|---|---|
| Silent alarm strategy | Experimental | The intervention consists of the implementation of a silent alarm system for the clinical environment. The silent alarm system consists of a self-locating interface device, which is interposed between an alarm-generating device and its audio output. This device contains communication, locating, motion, logic, and relay chips, which enable the interface device to identify its location and staff responsible for that location, as well as to detect audio output from the alarm-generating device, and to control the audible state of that output. The Interface device can communicate with separate bone conduction headsets worn by staff, which contain sensors that confirm staff presence at the headset, and buttons for response to an alarm announcement. The interface device then delivers alarms silently to those staff specifically responsible for its location when a responsible staff member can be identified, confirmed to be present, and accepts responsibility for the alarm through button action Receives: Other: Silent alarm strategy |
| Control | No intervention | In the control arm of the study, interface devices (as described in the experimental arm) will remain in place for data collection only, but will allow all alarms to be audible, and will not attempt silent alarms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment Method - (CAM-S long form)
The CAM-S Long form is a structured assessment to evaluate the presence and severity of delirium. It consists of a structured clinical assessment that has proven to be reproducible and an accurate measure of delirium presence and severity. The CAM-S has a scoring range of 0-19 with higher scores indicating a greater severity of delirium.
Measured: The CAM-S long form will be recorded every 12 hours during the four-week experimental period and also every 12 hours during the four-week control period.
Unit noise levels (Decibels)
Unit noise levels will be recorded using an integrating Decibel monitor measuring 10 second periods for A-weighted equivalent sound pressure levels (LA-EQ), and also C-weighted peak sound pressure (LC-Peak) for those same 10 second periods. Both LA-EQ and LC-Peak will be averaged, and reported on the Decibel scale, a logarithmic scale of sound pressure levels from 0 Db(least sound pressure) to 194 Db (maximum measurable sound pressure).
Measured: 10 seconds Decibel measurement periods will be recorded consecutively for two four-week periods, consisting of the four-week intervention period, and the four-week control period.
Alarm Fatigue
Alarm fatigue is an involuntary learned response among staff alarm responders that occurs over time. When presented with a high frequency of alarms which either lack specificity of the condition to which they intend to call attention, or which have a low frequency of required staff intervention ("nuisance alarms"), staff response times become extended, and in some cases, responses do not occur at all. This trial will track staff response time as the time from alarm initiation to staff button response, or alarm audio termination.
Alarm fatigue, assessed as the response time from alarm initiation to staff response (headset button response) or alarm audio termination, measured in seconds on every alarm occurring on every participating device during the study and control periods, each lasting four weeks. Time points for recording responses will be determined by alarm occurrence. Response times for the study and control periods will be averaged and compared statistically.
Measured: The staff response times will be measured (in seconds) for every alarm occurring during the four-week intervention and control periods.
Secondary outcomes (4)
Nursing Work
Nursing Work - Pedometer Measurements. All nurses in each participating unit will wear a pedometer during work shifts. Pedometers will record the number of steps taken during each shift. At the end of each shift, nurses will record the number of steps taken, and the length of the shift (hours). At the end of each four-week period as either study or control, the total number of steps recorded for nursing shifts in that unit will be divided by the total number of shift hours recorded in that unit over the four-week period, to determine the average hourly step count for that unit during the four-week period of either study or control unit.
Measured: Two four-week periods consisting of one four-week period as active intervention unit, and one four-week period as control unit.
Total Audio Time
The time that audio equipment generates an audio signal will be monitored and recorded. The total cumulative duration (in hours, minutes and seconds) that all monitored medical equipment generates audio output signals in the observed unit will be recorded for two four-week periods consisting of one four-week period while the unit serves as control, and a separate four-week intervention period.
Measured: Two four-week periods consisting of one four-week period for each unit as control arm, and one four-week period for each unit as intervention arm.
Use of medications intended to treat agitation
Use of haloperidol or dexmedetomidine
Measured: Cumulative doses of haloperidol and dexmedetomidine administered to all participants up to day 28 of the intervention and control periods.
Artificial intelligence observed rest
A camera based artificial intelligence system will observe sleep/wake appearance every 10 minutes in both intervention and control units for the two four-week study periods. This system has been trained to observe and differentiate the appearance of sleep and wake. The system will track sleep and wake appearance for each individual every 10 minutes for the two complete four-week periods of study and intervention arms.
Measured: Artificial intelligence observed rest will be monitored every 10 minutes for two four-week periods, consisting of the four-week control period and the four-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start3 Feb 2026
- Primary completion18 Apr 2026
- Study completion18 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindWave Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Daniel F Niendorff, MindWave Medical Inc
- Investigators
- Daniel F Niendorff, MD, Principal investigator, MindWave Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364097
- Sponsor's protocol ID
- D26
- Acronym
- DECIBEL
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Eliminating Alarm Noise Cacophony for Intensive Care Staff and Patients Improve Burnout and Encephalopathy Levels
- ClinicalTrials.gov ID
- NCT07364097
- Acronym / sponsor ID
- DECIBEL / D26
- Conditions
- Delirium in the Intensive Care Unit, Burnout, Healthcare Workers, Noise in the ICU, Alarm Fatigue, Alarm Fatigue in Intensive Care Unit Nurses, Alarms
- Keywords
- ICU delirium, alarm fatigue, silent alarm, alarm noise, nursing burnout, nursing work, alarm response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- MindWave Medical IncIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 23 Jan 2026 (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.
The goal of the trial is to learn if a strategy to eliminate audible alarm noise in intensive care and high dependency units can reduce overall noise levels, patient delirium, staff alarm fatigue, and staff burnout. Researchers will implement a silent alarm strategy in specific care units for four weeks and compare this to a separate 4 weeks where a silent strategy is not implemented. Noise, burnout, delirium levels, and staff alarm response times will be compared between the silent and non-silent units.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silent alarm strategy | Experimental | Other: Silent alarm strategyThe intervention consists of the implementation of a silent alarm system for the clinical environment. The silent alarm system consists of a self-locating interface device, which is interposed between an alarm-generating device and its audio output. This device contains communication, locating, motion, logic, and relay chips, which enable the interface device to identify its location and staff responsible for that location, as well as to detect audio output from the alarm-generating device, and to control the audible state of that output. The Interface device can communicate with separate bone conduction headsets worn by staff, which contain sensors that confirm staff presence at the headset, and buttons for response to an alarm announcement. The interface device then delivers alarms silently to those staff specifically responsible for its location when a responsible staff member can be identified, confirmed to be present, and accepts responsibility for the alarm through button action |
| Control | No intervention | –In the control arm of the study, interface devices (as described in the experimental arm) will remain in place for data collection only, but will allow all alarms to be audible, and will not attempt silent alarms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to Intensive or high dependency care unit.
Key exclusion criteria (3 listed)
- Pre-existing diagnosis of dementia
- Endotracheally intubated (may enroll when extubated)
- CNS injury, infection, or malignancy as reason for admission.
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 |
|---|---|---|
| Silent alarm strategyThe intervention consists of the implementation of a silent alarm system in the clinical environment. The silent alarm system consists of a self-locating interface device, which is interposed between an alarm-generating device and its audio output. This device contains communication, locating, motion, logic, and relay chips, which enable the interface device to identify its location and staff responsible for that location, as well as to detect audio output from the alarm-generating device, and to control the audible state of that output. The Interface device can communicate with separate bone conduction headsets worn by staff, which contain sensors that confirm staff presence at the headset, and buttons for response to an alarm announcement. The interface device then delivers alarms silently to those staff specifically responsible for its location when a responsible staff member can be identified, confirmed to be present, and accepts responsibility for the alarm through button action. | Other | Silent alarm strategy |
Primary outcome
Confusion Assessment Method - (CAM-S long form)
Time frame: The CAM-S long form will be recorded every 12 hours during the four-week experimental period and also every 12 hours during the four-week control period.
The CAM-S Long form is a structured assessment to evaluate the presence and severity of delirium. It consists of a structured clinical assessment that has proven to be reproducible and an accurate measure of delirium presence and severity. The CAM-S has a scoring range of 0-19 with higher scores indicating a greater severity of delirium.
Unit noise levels (Decibels)
Time frame: 10 seconds Decibel measurement periods will be recorded consecutively for two four-week periods, consisting of the four-week intervention period, and the four-week control period.
Unit noise levels will be recorded using an integrating Decibel monitor measuring 10 second periods for A-weighted equivalent sound pressure levels (LA-EQ), and also C-weighted peak sound pressure (LC-Peak) for those same 10 second periods. Both LA-EQ and LC-Peak will be averaged, and reported on the Decibel scale, a logarithmic scale of sound pressure levels from 0 Db(least sound pressure) to 194 Db (maximum measurable sound pressure).
Alarm Fatigue
Time frame: The staff response times will be measured (in seconds) for every alarm occurring during the four-week intervention and control periods.
Alarm fatigue is an involuntary learned response among staff alarm responders that occurs over time. When presented with a high frequency of alarms which either lack specificity of the condition to which they intend to call attention, or which have a low frequency of required staff intervention ("nuisance alarms"), staff response times become extended, and in some cases, responses do not occur at all. This trial will track staff response time as the time from alarm initiation to staff button response, or alarm audio termination. Alarm fatigue, assessed as the response time from alarm initiation to staff response (headset button response) or alarm audio termination, measured in seconds on every alarm occurring on every participating device during the study and control periods, each lasting four weeks. Time points for recording responses will be determined by alarm occurrence. Response times for the study and control periods will be averaged and compared statistically.
4 secondary outcomes
Nursing Work
Time frame: Two four-week periods consisting of one four-week period as active intervention unit, and one four-week period as control unit.
Total Audio Time
Time frame: Two four-week periods consisting of one four-week period for each unit as control arm, and one four-week period for each unit as intervention arm.
Use of medications intended to treat agitation
Time frame: Cumulative doses of haloperidol and dexmedetomidine administered to all participants up to day 28 of the intervention and control periods.
Artificial intelligence observed rest
Time frame: Artificial intelligence observed rest will be monitored every 10 minutes for two four-week periods, consisting of the four-week control period and the four-week intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
Daniel F Niendorff, MD principal investigator
MindWave Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silent alarm strategy in people with Delirium in the Intensive Care Unit and Burnout, Healthcare Workers, run by MindWave Medical Inc at 1 site in India.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confusion Assessment Method - (CAM-S long form) (time frame: The CAM-S long form will be recorded every 12 hours during the four-week experimental period and also every 12 hours during the four-week control period.). The study lists 3 primary outcomes in all. 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 Jul 2026.