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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
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.
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.
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 belowSelect...
I have been hospitalized in the internal medicine department for at least 3 nights.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep duration
Sleep fragmentation
Sound level changes ≥ 17.5 dB
+1 moreSecondary study objectives
Delirium Incidence
Delirium
Morning blood glucose
+4 moreTrial 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
58 Previous Clinical Trials
43,523 Total Patients Enrolled
1 Trials studying Sleep
120 Patients Enrolled for Sleep
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