SMART: Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual Care Usual care will be provided. |
|
| Active Comparator: Sound reduction Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used. |
Device: Sound reduction
Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
|
| Active Comparator: Sound masking Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking. |
Device: Sound masking
Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Other Outcome Measures
- Intra-individual nocturnal LF/HF ratio (a.u.) [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.
Eligibility Criteria
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
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Use of hearing aids, or known significant conductive or sensory hearing loss
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Brian Gehlbach
Investigators
- Principal Investigator: Brian K Gehlbach, MD, Faculty
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201609843