Clinical trial NCT03019133: Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Physiological Stress
Delirium
Sleep Deprivation
Keywords: Heart rate
Blood pressure variability
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nocturnal LF/HF ratio (a.u.)
timeFrame: Day 1 of study
Secondary outcomes:
measure: Nocturnal heart rate (bpm)
timeFrame: Day 1 of study
measure: Nocturnal RMSSD (ms)
timeFrame: Day 1 of study
measure: Nocturnal blood pressure (mm Hg)
timeFrame: Day 1 of study
measure: Incidence of ICU delirium
timeFrame: Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment
measure: Hospital length of stay (days)
timeFrame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
measure: ICU length of stay (days)
timeFrame: Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.
measure: Hospital mortality (%)
timeFrame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
measure: Discharged home (%, versus discharge to another health care facility or died)
timeFrame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
Other outcomes:
measure: Intra-individual nocturnal LF/HF ratio (a.u.)
timeFrame: Days 1 and 2 of study
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: Faculty
name: Brian K Gehlbach, MD
role: PRINCIPAL_INVESTIGATOR
References: