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Behavioral Intervention
Sleep Promotion App for High Blood Pressure
N/A
Waitlist Available
Led By Jonathan Mitchell, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recently diagnosed with essential hypertension by Ambulatory Blood Pressure Monitoring (ABPM)
Be younger than 65 years old
Must not have
Any clinically diagnosed sleep disorder (e.g. sleep apnea) in the electronic health record and or regular use of prescribed sleep aide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to approximately week 11
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if using a mobile health app can help kids with kidney problems sleep better and lower their blood pressure.
Who is the study for?
This trial is for children with high blood pressure potentially linked to not getting enough sleep. Participants should be currently receiving care in a pediatric nephrology setting. The specific inclusion and exclusion criteria are not provided, but typically would detail age range, health status, and other relevant factors.
What is being tested?
The study is testing whether using mobile health technology to encourage more sleep can help kids sleep longer and lower their blood pressure. It's likely that the approach involves an app or device designed to promote better sleep habits.
What are the potential side effects?
Since this intervention focuses on non-invasive methods like improving sleep through mobile health technology, side effects may be minimal or related to changes in lifestyle rather than medication-related risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been recently diagnosed with high blood pressure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed sleep disorder or use prescribed sleep aids regularly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to approximately week 11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to approximately week 11
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sleep tracker estimated weeknight sleep duration
Hypertension
Secondary study objectives
Change in daytime systolic/diastolic blood pressures as measured by Ambulatory Blood Pressure Monitoring (ABPM)
Change in night time systolic/diastolic blood pressures as measured by ABPM
Change in sleep tracker estimated sleep duration
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73780
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,473,024 Total Patients Enrolled
Jonathan Mitchell, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
5,000 Total Patients Enrolled
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