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

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.

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