A Study of Silent Alarm Delivery Versus Standard Audible Alarm Delivery in Intensive Care and High Dependency Units (DECIBEL)

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.

Study Overview

• Status: Completed
• Conditions: Nursing Workload; Burnout, Healthcare Workers; Alarm Fatigue; Delirium in the Intensive Care Unit; Alarms; Noise in the ICU; Alarm Fatigue in Intensive Care Unit Nurses
• Intervention / Treatment: Other: Silent alarm strategy

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Andrah Pradesh
    • Nandyāl, Andrah Pradesh, India, 518502
      • Udayananda Multispecialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admission to Intensive or high dependency care unit.

Exclusion Criteria:

• Pre-existing diagnosis of dementia
• Endotracheally intubated (may enroll when extubated)
• CNS injury, infection, or malignancy as reason for admission.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silent alarm strategy; 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	Other: Silent alarm strategy; 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.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	The staff response times will be measured (in seconds) for every alarm occurring during the four-week intervention and control periods.
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Silent vs Audible alarm time	The total and proportional alarm time that equipment spent in audible and silent states will be recorded during the intervention period.	This proportional measurement will serve as a baseline for future investigators

Collaborators and Investigators

• Sponsor: MindWave Medical Inc
• Investigators: Principal Investigator: Daniel F Niendorff, MD, MindWave Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Actual): April 18, 2026
• Study Completion (Actual): April 18, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ICU delirium; alarm fatigue; silent alarm; alarm noise; nursing burnout; nursing work; alarm response
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Fatigue; Mental Fatigue; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Burnout, Psychological; Alert Fatigue, Health Personnel
• Other Study ID Numbers: D26

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