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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: Recruiting NA study of Sleep and Sleep Fragmentation, sponsored by Scripps Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What NCT05475262 shows while recruiting
NCT05475262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05475262's enrollment target sits among peer trials
50 102nd of 151 higher than 46 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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