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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual care will be provided. | |
| Sound reduction | Active Comparator | Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used. |
|
| Sound masking | Active Comparator | Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound reduction | Device | Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal heart rate (bpm) | The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined. | Day 1 of study |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian K Gehlbach, MD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 201609843 | Informed Consent Form | View IPD |
As this is a pilot study, there are no definite plans for sharing individual participant data at this time.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003693 | Delirium |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
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| Sound masking | Device | Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am. |
|
| Day 1 of study |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |