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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Physiological Stress Delirium Sleep Deprivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care

Usual care will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Sound reduction

Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.

Group Type ACTIVE_COMPARATOR

Sound reduction

Intervention Type DEVICE

Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.

Sound masking

Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.

Group Type ACTIVE_COMPARATOR

Sound masking

Intervention Type DEVICE

Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.

Interventions

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Sound reduction

Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.

Intervention Type DEVICE

Sound masking

Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No