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NCT05475262 · ClinicalTrials.gov registry record · NA
Sleepless at Scripps: An Inpatient White Noise Study
A NA study of Sleep and Sleep Fragmentation, sponsored by Scripps Health.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05475262 is a NA study of Sleep and Sleep Fragmentation that is actively recruiting participants, run by Scripps Health. The registered enrollment target is 50 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05475262, a NA study of Sleep and Sleep Fragmentation, is actively recruiting participants, sponsored by Scripps Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (which refers to an increase in sound above the background/baseline noise level) may cause arousals from sleep. Based on preliminary data, this study aims to use white noise to reduce the number of relevant sound level changes that occur during a night of sleep in the hospital. Using a randomized, cross-over design, the investigators aim to enroll 45 inpatient adults (age ≥ 65 years) to receive "active," white noise (white noised played at 57-60 decibels) on one night of their stay, and "inactive," white noise (white noise played at 45-50 decibels) on an alternate night. Three major primary outcomes will be investigated - 1) objective sleep duration as measured using actigraphy, 2)objectively measured sleep fragmentation using actigraphy, and 3) subjective sleep quality using the Richards Campbell Sleep Questionnaire. Secondary outcomes will include sound level changes in the room (measured using sound meters), as well as morning blood glucose (for diabetic/prediabetic patients) and blood pressure measurements. Delirium will be measured twice daily through the inpatient stay in a secondary analysis to compare levels of sleep fragmentation to delirium incidence.
Conditions Studied
Interventions
- DEVICE Active white noise
- DEVICE Inactive white noise
Study Locations (1)
California
- Scripps Health - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05475262
The ClinicalTrials.gov registry entry for NCT05475262 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (99% lower). The listed sponsor is Scripps Health, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Active white noise is the first listed.
NCT05475262 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05475262 about?
NCT05475262 is a clinical study titled "Sleepless at Scripps: An Inpatient White Noise Study". Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (whi...
What is the current status of trial NCT05475262?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-07-28. Estimated completion is 2027-02-01.
What conditions does trial NCT05475262 study?
This clinical trial studies the following conditions: Sleep, Sleep Fragmentation, Sleep Duration, White Noise.
What interventions are being tested in trial NCT05475262?
The interventions under investigation include: Active white noise (DEVICE), Inactive white noise (DEVICE).
Who is sponsoring clinical trial NCT05475262?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05475262 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.