Sleep Promotion and Pediatric Hypertension

NCT06642246 | Recruiting

• 1 other identifier: 24-022262
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insufficient Sleep; Hypertension

Keywords

Insufficient Sleep; Hypertension

Outcome Measures

Primary Outcomes (2)

• Hypertension

  The number of participants who are still diagnosed with hypertension by ambulatory blood pressure monitoring (ABPM). This is defined as a mean systolic or diastolic blood pressure when either awake or asleep, greater than the 95th percentile.

  From baseline to approximately week 11

• Change in sleep tracker estimated weeknight sleep duration

  Change in sleep tracker estimated weeknight sleep duration will be measured from baseline (operationalized as the average hours per weeknight per week). There will be one week of baseline data and seven weeks of intervention data as well as two weeks of follow-up data.

  From baseline to approximately week 11

Secondary Outcomes (4)

• Change in sleep tracker estimated sleep duration

  From baseline to approximately week 11

• Changes in sleep disturbance score measured by the Patient-Reported Outcome Measurement System (PROMIS) tool

  From baseline to approximately week 11

• Change in daytime systolic/diastolic blood pressures as measured by Ambulatory Blood Pressure Monitoring (ABPM)

  From baseline to approximately week 11

• Change in night time systolic/diastolic blood pressures as measured by ABPM

  From baseline to approximately week 11

Study Arms (1)

Arm 1

EXPERIMENTAL

Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.

Behavioral: Intervention

Interventions

Intervention 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.

Arm 1

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Be the parent/guardian of an eligible child enrolled in the main study.
• Speak, read, and write in English.
• \- Limited English proficiency

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Sleep Deprivation; Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jonathan Mitchell, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Mitchell

CONTACT

267-426-1473; mitchellj2@chop.edu

Abby Salem

CONTACT

215-590-2386; salema1@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: February 16, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)