Skip to main content
OpenTrials
Completed

NCT Number: NCT03019133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound reduction

Device

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

Sound masking

Device

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

Primary outcomes

  1. Nocturnal LF/HF ratio (a.u.)

    Time frame: 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 outcomes

  1. Nocturnal heart rate (bpm)

    Time frame: Day 1 of study

    The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.

  2. Nocturnal RMSSD (ms)

    Time frame: 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.

  3. Nocturnal blood pressure (mm Hg)

    Time frame: Day 1 of study

    The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.

  4. Incidence of ICU delirium

    Time frame: 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.

  5. Hospital length of stay (days)

    Time frame: 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.

  6. ICU length of stay (days)

    Time frame: 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.

  7. Hospital mortality (%)

    Time frame: 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.

  8. Discharged home (%, versus discharge to another health care facility or died)

    Time frame: 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.

Other outcomes

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

    Time frame: Days 1 and 2 of study

    For each subject, the effect of treatment assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined by comparing the LF/HF ratio on Day 1 (intervention) with that on Day 2.

Sponsors and collaborators

Lead sponsor

Brian Gehlbach

Other

Registry information

Official study title

Prospective Randomized Controlled Trial to Compare and Analyze the Effects of Sound Masking and Reduction Techniques on Heart Rate and Blood Pressure Variability in Critically Ill Patients

Acronym: SMART

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2017
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.