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

NCT03019133 | Completed

• 1 other identifier: 201609843
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Physiological Stress; Delirium; Sleep Deprivation

Keywords

Heart rate; Blood pressure variability

Outcome Measures

Primary Outcomes (1)

• Nocturnal LF/HF ratio (a.u.)

  The effect of group assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined.

  Day 1 of study

Secondary Outcomes (8)

• Nocturnal heart rate (bpm)

  Day 1 of study

• Nocturnal RMSSD (ms)

  Day 1 of study

• Nocturnal blood pressure (mm Hg)

  Day 1 of study

• 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

• 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.

Other Outcomes (1)

• Intra-individual nocturnal LF/HF ratio (a.u.)

  Days 1 and 2 of study

Study Arms (3)

Usual Care

NO INTERVENTION

Usual care will be provided.

Sound reduction

ACTIVE COMPARATOR

Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.

Device: Sound reduction

Sound masking

ACTIVE COMPARATOR

Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.

Device: Sound masking

Interventions

Sound reduction DEVICE

Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.

Sound reduction

Sound masking DEVICE

Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.

Sound masking

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian Gehlbach: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Critical Illness; Delirium; Sleep Deprivation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders

Study Officials

• Brian K Gehlbach, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 12, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)