Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness; Physiological Stress; Delirium; Sleep Deprivation
• Interventions: Device: Sound masking; Device: Sound reduction

• Registration Number: NCT03019133
• Lead Sponsor: Brian Gehlbach

Brief Summary

The goal of the project is to determine the effects of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the intensive care unit.

Detailed Description

Sleep deprivation is common in critically ill patients in the intensive care unit (ICU) and may impair recovery. While noise is widely cited as the most common cause of sleep disruption in the ICU setting, its contribution to sympathetic activity in critically ill patients is not known. This is an important knowledge gap, because noise initiates a sequence of physiological changes including vasoconstriction, raised diastolic blood pressure, pupil dilatation and muscle tension. Furthermore, noise is implicated in sympathetic arousals, resulting in a release of adrenaline which prevents relaxation and consequently prevents the patient from falling asleep.

The investigators plan to study the effect of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the ICU. Subjects will be randomized into 3 separate groups: control, noise reduction, and noise masking. The investigators will compare the heart rate and blood pressure variability between and within the groups to determine the effects of treatment assignment on these variables. Non-invasive measurements obtained from the bedside monitor will be collected using physiological data acquisition software.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours

Exclusion Criteria

• Admission for drug overdose or with a known substance abuse disorder
• Untreated sleep apnea disorder, narcolepsy, REM sleep behavior disorder, parasomnia, restless leg syndrome or other sleep disorder
• Use of hearing aids, or known significant conductive or sensory hearing loss
• Ventilator support via an endotracheal tube
• Use of vasopressors
• Unresponsive or delirious
• Subjects with known Dementia, Parkinson's disease, or other neurodegenerative disorder
• Subjects with a pacemaker or who have received cardiac transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sound masking	Sound masking	Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.
Sound reduction	Sound reduction	Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.

Primary Outcome Measures

Name	Time	Method
Nocturnal LF/HF ratio (a.u.)	Day 1 of study	The effect of group assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined.

Secondary Outcome Measures

Name	Time	Method
Hospital mortality (%)	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.	The effect of group assignment on in-hospital mortality will be assessed.
Incidence of ICU delirium	Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment	The effect of group assignment on the incidence of ICU delirium as assessed by the CAM-ICU will be determined.
Nocturnal heart rate (bpm)	Day 1 of study	The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.
Nocturnal RMSSD (ms)	Day 1 of study	The effect of group assignment on nocturnal (8pm to 8am) root mean square of sequential differences of RR intervals (RMSSD) will be determined.
Nocturnal blood pressure (mm Hg)	Day 1 of study	The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.
Hospital length of stay (days)	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.	The effect of group assignment on hospital length of stay will be assessed.
Discharged home (%, versus discharge to another health care facility or died)	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.	The effect of group assignment on being discharged directly to home (versus to another skilled care facility or died) from the hospital will be assessed.
ICU length of stay (days)	Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.	The effect of group assignment on ICU length of stay will be assessed.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States