University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
NCT Number: NCT03019133
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
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.
Time frame: Day 1 of study
The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.
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.
Time frame: Day 1 of study
The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.
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.
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.
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.
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.
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.
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.
Brian Gehlbach
Other
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
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.
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