Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients
NCT03019133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-04-06
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.
Conditions
- Critical Illness
- Physiological Stress
- Delirium
- Sleep Deprivation
Interventions
- DEVICE
-
Sound reduction
Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
- DEVICE
-
Sound masking
Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
Sponsors & Collaborators
-
Brian Gehlbach
lead OTHER
Principal Investigators
-
Brian K Gehlbach, MD · Faculty
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- United States
Study Locations
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