A mobile sleep program to help teens with high blood pressure sleep longer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, home-based feasibility trial at the Children's Hospital of Philadelphia enrolling 10 adolescents (five parent-child dyads) aged 13–18 with recently diagnosed essential hypertension who currently spend ≤7.5 hours in bed on school nights. After a two-week run-in to capture baseline sleep using a provided sleep tracker and a home sleep polysomnography for clinical data, participants enter a seven-week intervention delivered via REDCap. The intervention is a mobile health sleep promotion platform aimed at extending sleep duration while avoiding participants with known clinical sleep disorders or current antihypertensive therapy. Primary outcomes include change in sleep duration and changes in systolic and diastolic blood pressure, along with feasibility metrics for delivering the program in a pediatric nephrology setting.

Why it matters

Who can join: the full rules

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.

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).

Inclusion Criteria for Parents/Legal Guardians:

* Be the parent/guardian of an eligible child enrolled in the main study.
* Speak, read, and write in English.

Exclusion Criteria for Parents/Legal Guardians:

\- Limited English proficiency

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jonathan Mitchell, PhD — Children's Hospital of Philadelphia
• Study coordinator: Jonathan Mitchell
• Email: mitchellj2@chop.edu
• Phone: 267-426-1473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.