- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475262
Sleepless at Scripps: An Inpatient White Noise Study
Sleepless at Scripps: The Use of White Noise to Increase Sleep Duration in Hospitalized Patients, a Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods (Intervention and Study Design). This study will use a randomized cross-over framework. The investigators have chosen a design that will allow for pair-wise comparisons of sleep for each participant. Participants will receive white noise on the 2nd (night A) and 3rd (night B) night of the hospital stay. Patients will be randomized to receive inactive white noise (45-50 dB) on either night A or B and active white noise (57-60 dB) on the alternate night. An unblinded study staff member will dispense a machine calibrated to either active or inactive white noise on the first night, and will switch the machine setting the following day. Devices will be programmed to turn on at 10 PM and off at 6 AM automatically. Decibel level (the machine has 10 preset decibel settings) and start/stop times will be programmed using the manufacturer's smartphone application. One smartphone or tablet (available from prior studies at SRTI) will be assigned to each white noise device, password protected, and stored with the device in the unblinded study staff member's office. The noise level chosen for control (or the inactive white noise) is below that of the background noise of the hospital and should theoretically not have any impact on sound level changes ≥ 17.5 dB (Fig. 3), but will help maintain blinding of staff, participants, and researchers.
Methods (Measurement of outcomes and covariates): Objectively measured sleep metrics will be obtained from actigraphy devices. These include (over the 10PM-6AM period) total sleep time, sleep fragmentation (using mean/median sleep bout length), and number of nighttime awakenings. The investigators will also measure total sleep duration in each 24-hour period. Subjective sleep will be measured using the validated Richards Campbell Sleep Questionnaire (RCSQ). Delirium will be measured twice daily using the Confusion Assessment Method (CAM). AM blood pressure and glucose readings (for diabetic/prediabetic patients) will be obtained from the EMR. Pain scores and opioid administration will also be extracted from the EMR. Pertinent covariates will include age, comorbidities (using Charlson comorbidity index), baseline cognitive status (MoCA assessment), and severity of illness as measured by the highest Modified Early Warning System (MEWS) score for each patient.
Statistical analysis plan: This power analysis is conducted based on a change in sleep fragmentation (as measured by sleep bout length, Fig. 1). The investigators previously found that a 2.5-minute difference in mean sleep bout length between delirious vs. non-delirious patients,8 suggesting that a difference of this magnitude could have clinical significance. Using these prior data, the investigators calculated an effect size (Cohen's d coefficient) of 0.58. The investigators subsequently used G-Power (v. 3.1) software to calculate power using the following parameters: 1) Difference between two dependent means (matched pairs), 2) 2-tailed t-test, 3) P-value (alpha) <0.05), and power of 90%. Based on these calculations, the investigators expect a total sample size of 34 individuals. Expecting a 20% attrition rate (including early/unexpected discharges, technical error, or patient dropout), the investigators conservatively aim to enroll 45 patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stuti Jaiswal, MD, PhD
- Phone Number: 858-554-7909
- Email: JAISWAL.STUTI@SCRIPPSHEALTH.ORG
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- Scripps Health
-
Contact:
- Shelly L Meese
- Phone Number: 636-893-4407
- Email: meese.shelly@scrippshealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years old
- Admitted to inpatient internal medicine service for at least 3 nights
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Night A active white noise
Patients receiving active level of white noise on night A
|
Active white noise of 57 dB - 60 dB from 10 pm to 6 am
|
Sham Comparator: Night B inactive white noise
Patients will receive a lower Level of white noise on night B. Termed "inactive," because do not expect the level to have a noticeable change in sound level changes, and thus sleep.
|
Sham comparator - white noise machine played at lower decibel level not expected to impact sound level changes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sound level changes ≥ 17.5 dB
Time Frame: 72 hours
|
Change in sound level changes ≥ 17.5dB between inactive and active white noise intervention.
This will be using sound level measurements obtained from sound meters placed in patient rooms
|
72 hours
|
Sleep duration
Time Frame: 72 hours
|
Measured between patients receiving active vs. inactive white noise in minutes using wrist-worn actigraphy devices
|
72 hours
|
Sleep fragmentation
Time Frame: 72 hours
|
Measured using mean and median sleep bout duration from actigraphy devices in patients receiving active vs. inactive white noise.
|
72 hours
|
Subjective sleep quality
Time Frame: 72 hours
|
Measured using Richards Campbell Sleep Questionnaire.
Assesses subjective sleep in patients who received active white noise.
vs. inactive white noise.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delirium Incidence
Time Frame: 72 hours
|
Measured using bCAM.
Comparing rates of delirium incidence between patients receiving active vs. inactive white noise.
|
72 hours
|
Morning blood glucose
Time Frame: 72 hours
|
Measured using morning metabolic panels OR point-of-care glucose testing.
|
72 hours
|
Morning blood pressure reading
Time Frame: 72 hours
|
Measured using standard of care vital signs, both systolic and diastolic measurements.
|
72 hours
|
Delirium incidence based on sleep fragmentation
Time Frame: 72 hours
|
Measured using bCAM.
In a secondary analysis, the investigators will test whether those individuals with higher sleep fragmentation, as measured by actigraphy, will have a higher incidence of delirium compared to those with lower levels of sleep fragmentation.
|
72 hours
|
Morning blood pressure based on sleep fragmentation
Time Frame: 72 hours
|
Measured using standard morning vital signs.
In a secondary analysis, the investigators will test whether those individuals with higher sleep fragmentation, as measured by actigraphy, will have higher systolic/diastolic blood pressure readings compared to those with lower levels of sleep fragmentation.
|
72 hours
|
Morning blood glucose based on sleep fragmentation
Time Frame: 72 hours
|
Measured using standard morning metabolic panel OR point-of-care glucose testing.
In a secondary analysis, the investigators will test whether those individuals with higher sleep fragmentation, as measured by actigraphy, will have higher morning blood glucose readings compared to those with lower levels of sleep fragmentation.
|
72 hours
|
Opioid use
Time Frame: 72 hours
|
Measured using morphine milligram equivalent totals over the white noise testing period.
In a secondary analysis, the investigators will test whether those individuals with higher sleep fragmentation, as measured by actigraphy, will have more opioid use compared to those with lower levels of sleep fragmentation.
|
72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- White noise
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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