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

Critical Illness Clinical Trial

— SMART  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03019133
• Other study ID #: 201609843
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Physiological Stress
• Sleep Deprivation

Intervention

Device:
• Sound reduction
Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
• Sound masking
Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Brian Gehlbach

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-individual nocturnal LF/HF ratio (a.u.)	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.	Days 1 and 2 of study
Primary	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	Nocturnal heart rate (bpm)	The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.	Day 1 of study
Secondary	Nocturnal RMSSD (ms)	The effect of group assignment on nocturnal (8pm to 8am) root mean square of sequential differences of RR intervals (RMSSD) will be determined.	Day 1 of study
Secondary	Nocturnal blood pressure (mm Hg)	The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.	Day 1 of study
Secondary	Incidence of ICU delirium	The effect of group assignment on the incidence of ICU delirium as assessed by the CAM-ICU will be determined.	Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment
Secondary	Hospital length of stay (days)	The effect of group assignment on hospital length of stay will be assessed.	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
Secondary	ICU length of stay (days)	The effect of group assignment on ICU length of stay will be assessed.	Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.
Secondary	Hospital mortality (%)	The effect of group assignment on in-hospital mortality will be assessed.	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
Secondary	Discharged home (%, versus discharge to another health care facility or died)	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.	Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.