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

NCT07364097 | Completed

• 1 other identifier: D26
• Study Type: interventional
• Target: 896
• Locations: 1 country
• Sites: 1

Brief 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. 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

Alarm Fatigue in Intensive Care Unit Nurses; Alarms; Nursing Workload; Delirium in the Intensive Care Unit; Burnout, Healthcare Workers; Noise in the ICU; Alarm Fatigue

Keywords

ICU delirium; alarm fatigue; silent alarm; alarm noise; nursing burnout; nursing work; alarm response

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

Secondary Outcomes (4)

• Nursing Work

  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

  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

  Cumulative doses of haloperidol and dexmedetomidine administered to all participants up to day 28 of the intervention and control periods.

• Artificial intelligence observed rest

  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 Outcomes (1)

• Silent vs Audible alarm time

  This proportional measurement will serve as a baseline for future investigators

Study Arms (2)

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

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.

Interventions

Silent alarm strategy OTHER

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.

Silent alarm strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to Intensive or high dependency care unit.

You may not qualify if:

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

Sponsors & Collaborators

• MindWave Medical Inc: lead

Study Sites (1)

Udayananda Multispecialty Hospital

Nandyāl, Andrah Pradesh, 518502, India

Location

MeSH Terms

Conditions

Burnout, Psychological; Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel F Niendorff, MD

  MindWave Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: February 3, 2026
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)