A study of silent alarm delivery versus standard audible alarm delivery

Does eliminating alarm noise cacophony for intensive care staff and patients improve burnout and encephalopathy levels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13528343

Enrollment

200

Registered

2026-01-08

Start date

2026-02-03

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of delirium in adults receiving inpatient high dependency or intensive care. Mental and Behavioural Disorders

Interventions

The intervention will consist of implementing a silent alarm delivery system that will communicate alarms to staff wirelessly using a bone conduction headset, which verifies human presence. This inter

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 06/02/2026: 1. Admission to an intensive care or high dependency care unit 2. Age greater than 18 years _____ Previous key inclusion criteria: 1. Admission to an intensive care or high dependency or intensive care unit 2. Age greater than 18 years

Exclusion criteria

Exclusion criteria: Current key exclusion criteria as of 06/02/2026: 1. Patients with a previous diagnosis of dementia 2. Patients with a diagnosis of CNS trauma, infection, or malignancy as the reason for admission. 3. Patients currently requiring endotracheal intubation _____ Previous key exclusion criteria: 1. Patients with a previous diagnosis of dementia 2. Patients with a diagnosis of brain injury leading to this admission 3. Patients currently requiring endotracheal intubation

Design outcomes

Primary

Measure	Time frame
Previous primary outcome(s): 1. Alarm fatigue, assessed from the response time from alarm initiation to staff response (headset button response) or alarm audio termination, measured using data collection on every alarm occurring on every participating device during the study and control periods, each lasting 4 weeks at one time point 2. Staff burnout measured using the Maslach Burnout Survery at days 0, 7, 14, 21, and 28 of the study and intervention periods 3. Delirium severity measured using the Confusion Assessment Method (CAM) at a daily assessment 4. Global noise level, assessed by Decibel Level Monitoring (LAeq integrated at 10-second intervals and LCpeak for the same 10-second intervals), measured using the SoftDB Piccolo-II integrating decibel meter (SoftDB.com) at a continuous sampling rate through the intervention and control periods	—

Measure

Time frame

Previous primary outcome(s): 1. Alarm fatigue, assessed from the response time from alarm initiation to staff response (headset button response) or alarm audio termination, measured using data collection on every alarm occurring on every participating device during the study and control periods, each lasting 4 weeks at one time point 2. Staff burnout measured using the Maslach Burnout Survery at days 0, 7, 14, 21, and 28 of the study and intervention periods 3. Delirium severity measured using the Confusion Assessment Method (CAM) at a daily assessment 4. Global noise level, assessed by Decibel Level Monitoring (LAeq integrated at 10-second intervals and LCpeak for the same 10-second intervals), measured using the SoftDB Piccolo-II integrating decibel meter (SoftDB.com) at a continuous sampling rate through the intervention and control periods

—

Secondary

Measure	Time frame
Added 20/04/2026: 3.	—

Countries

India

Contacts

Public ContactDaniel Niendorff

dan@niendorff.org+1 865 528 1004

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026