Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-02-28
Study Completion Date
2026-06-30
Brief Summary
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Determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
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Detailed Description
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Insufficient sleep is associated with hypertension in children. Despite this knowledge, sleep promotion is not considered as a behavioral target during the initial treatment of pediatric essential hypertension. Investigators are developing a mobile platform to promote sleep in children that may have utility for treating pediatric essential hypertension.
The overall objective of this study is to determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
This is a home-based, single-site study, of 13-to-18-year-olds (N=10, 5 parent-child dyads). Participants will have a recent diagnosis of essential hypertension, based on clinical ambulatory blood pressure monitoring, with initial treatment targeting lifestyle modification without pharmacological therapy. Participants must have cellular or internet access and spend less than or equal to 7.5 hours in bed per night. Children will be excluded if they have a known clinical sleep disorder.
The sleep promotion intervention will be delivered using REDCap. All participants will be provided with a sleep tracker to monitor their sleep patterns throughout the study. A two-week run-in phase will be used to capture baseline sleep patterns, and a home sleep polysomnography test will be completed to provide clinical sleep data. During a 7-week intervention phase, all participants will receive the same intervention condition. Participants will be provided a sleep duration goal paired with a loss-framed financial incentive (virtual account) starting with deductions each time the sleep goal is not met, will be sent sleep guidance text messages, and will receive weekly performance feedback text messages. Further, at the end of the intervention phase, participants will undergo a second Ambulatory Blood Pressure Monitoring (ABPM). The primary outcome is acceptance and feasibility of completing this study captured via self-reported feedback and documenting compliance with the study protocol. The secondary outcomes are changes in sleep duration from baseline, and changes in daytime and nocturnal systolic and diastolic blood pressure from baseline.
The overall objective of this study is to determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
This is a home-based, single-site study, of 13-to-18-year-olds (N=10, 5 parent-child dyads). Participants will have a recent diagnosis of essential hypertension, based on clinical ambulatory blood pressure monitoring, with initial treatment targeting lifestyle modification without pharmacological therapy. Participants must have cellular or internet access and spend less than or equal to 7.5 hours in bed per night. Children will be excluded if they have a known clinical sleep disorder.
The sleep promotion intervention will be delivered using REDCap. All participants will be provided with a sleep tracker to monitor their sleep patterns throughout the study. A two-week run-in phase will be used to capture baseline sleep patterns, and a home sleep polysomnography test will be completed to provide clinical sleep data. During a 7-week intervention phase, all participants will receive the same intervention condition. Participants will be provided a sleep duration goal paired with a loss-framed financial incentive (virtual account) starting with deductions each time the sleep goal is not met, will be sent sleep guidance text messages, and will receive weekly performance feedback text messages. Further, at the end of the intervention phase, participants will undergo a second Ambulatory Blood Pressure Monitoring (ABPM). The primary outcome is acceptance and feasibility of completing this study captured via self-reported feedback and documenting compliance with the study protocol. The secondary outcomes are changes in sleep duration from baseline, and changes in daytime and nocturnal systolic and diastolic blood pressure from baseline.
Conditions
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Insufficient Sleep
Hypertension
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The study conditions are as follows: sleep goal, digital sleep guidance, loss-framed financial incentive, and personalized feedback. All participants need to self-monitor their sleep duration by wearing the sleep tracker to allow for daily capture of sleep duration and goal achievement status.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Arm 1
Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.
Group Type
EXPERIMENTAL
Intervention
Intervention Type
BEHAVIORAL
During a 7-week intervention phase, parent-child dyads will be provided a sleep duration goal paired with a loss-framed financial incentive (virtual account) starting with deductions each time the sleep goal is not met, will be sent sleep guidance text messages, and will receive weekly performance feedback text messages.
Interventions
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Intervention
During a 7-week intervention phase, parent-child dyads will be provided a sleep duration goal paired with a loss-framed financial incentive (virtual account) starting with deductions each time the sleep goal is not met, will be sent sleep guidance text messages, and will receive weekly performance feedback text messages.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Speak, read and write in English.
* Parental/guardian permission (informed consent) and child assent.
* Have a computer or a tablet computer with access to the Internet or own a smartphone with a data and text plan.
* Parent reported sleep duration on school nights less than or equal to 7.5 hours.
* Recently diagnosed with essential hypertension by Ambulatory Blood Pressure Monitoring (ABPM).
* If taking over the counter sleep aides, willing to stop them over the course of the study.
* Be the parent/guardian of an eligible child enrolled in the main study.
* Speak, read, and write in English.
* Parental/guardian permission (informed consent) and child assent.
* Have a computer or a tablet computer with access to the Internet or own a smartphone with a data and text plan.
* Parent reported sleep duration on school nights less than or equal to 7.5 hours.
* Recently diagnosed with essential hypertension by Ambulatory Blood Pressure Monitoring (ABPM).
* If taking over the counter sleep aides, willing to stop them over the course of the study.
* Be the parent/guardian of an eligible child enrolled in the main study.
* Speak, read, and write in English.
Exclusion Criteria
* Any clinically diagnosed sleep disorder (e.g. sleep apnea) in the electronic health record and or regular use of prescribed sleep aide.
* Underlying chronic medical conditions, defined as a medical condition with a duration or expected duration longer than 3 months that involved taking regular medication, taking medications that could affect blood pressure (e.g., anti-hypertensive medications, glucocorticoids, or stimulants), and patients with underlying diagnoses known to be associated with elevated blood pressure (e.g., cardiac disease, kidney disease or diabetes).
\- Limited English proficiency
* Underlying chronic medical conditions, defined as a medical condition with a duration or expected duration longer than 3 months that involved taking regular medication, taking medications that could affect blood pressure (e.g., anti-hypertensive medications, glucocorticoids, or stimulants), and patients with underlying diagnoses known to be associated with elevated blood pressure (e.g., cardiac disease, kidney disease or diabetes).
\- Limited English proficiency
Minimum Eligible Age
13 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jonathan Mitchell, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Mitchell JA, Morales KH, Williamson AA, Jawahar A, Juste L, Vajravelu ME, Zemel BS, Dinges DF, Fiks AG. Promoting Sleep Duration in the Pediatric Setting Using a Mobile Health Platform: A Randomized Optimization Trial. medRxiv [Preprint]. 2023 Jan 5:2023.01.04.23284151. doi: 10.1101/2023.01.04.23284151.
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BACKGROUND
Other Identifiers
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24-022262
Identifier Type: -
Identifier Source: org_study_id
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