Critical Illness, Delirium, Physiological Stress, Sleep Deprivation
Conditions
Keywords
Heart rate, Blood pressure variability
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.
Interventions
DEVICESound reduction
Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
DEVICESound masking
Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
Sponsors
Brian Gehlbach
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed