White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study
1 other identifier
interventional
7
1 country
1
Brief Summary
A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedApril 1, 2019
March 1, 2019
4 months
November 26, 2018
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Intervention fidelity: percent of intervention time during which white noise is actually delivered
percent of intervention time during which white noise is actually delivered
48 hours
Secondary Outcomes (5)
Sound Levels
48 hours
Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.
48 hours
Actigraphic rest-activity :Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.
48 hours
Patient tolerance: percent of days that patients agree to continue white noise
48 hours
Patient acceptance: percent of patients or surrogates who agree to receive white noise at night
48 hours
Study Arms (2)
patients exposed to white noise
EXPERIMENTALSix patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined; pausing will be at nurse, provider, and patient discretion during routine care and conversations with the patients.
usual care
PLACEBO COMPARATORSix patients exposed to normal ICU activity noise.
Interventions
Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.
Eligibility Criteria
You may qualify if:
- Adults \>18yo admitted to MICU with expected stay of at least two nights after enrollment
You may not qualify if:
- Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
- Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Gao, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2018
First Posted
November 27, 2018
Study Start
November 27, 2018
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
April 1, 2019
Record last verified: 2019-03