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Night A active white noise for Sleep Fragmentation

N/A
Recruiting
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to inpatient internal medicine service for at least 3 nights
Over 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial aims to improve sleep quality for patients in the hospital by using white noise. Many patients have trouble falling asleep and staying asleep due to noise in the hospital. The researchers will enroll 45 adults

Who is the study for?
This trial is for adults over 18 who are admitted to the inpatient internal medicine service for at least three nights. It's designed to help those experiencing poor sleep in the hospital by testing if white noise can improve their sleep quality and duration.Check my eligibility
What is being tested?
The study compares two levels of white noise: 'active' (57-60 decibels) and 'inactive' (45-50 decibels). Each participant will experience both on different nights. The effects on sleep duration, fragmentation, and subjective quality will be measured, along with room noise levels, blood glucose, blood pressure, and delirium incidence.See study design
What are the potential side effects?
There may not be significant side effects from this intervention as it involves only exposure to different levels of white noise during sleep. However, some individuals might find certain sound levels uncomfortable or disruptive to their rest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been hospitalized in the internal medicine department for at least 3 nights.
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I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep duration
Sleep fragmentation
Sound level changes ≥ 17.5 dB
+1 more
Secondary outcome measures
Delirium Incidence
Delirium
Morning blood glucose
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Night A active white noiseExperimental Treatment1 Intervention
Patients receiving active level of white noise on night A
Group II: Night B inactive white noisePlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Scripps HealthLead Sponsor
56 Previous Clinical Trials
43,443 Total Patients Enrolled
~10 spots leftby Jan 2025
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