A mobile sleep program to help teens with high blood pressure sleep longer
Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension
NA · Children's Hospital of Philadelphia · NCT06642246
This trial tries a phone/computer-based sleep extension program for 13-to-18-year-olds with recently diagnosed high blood pressure to see if they sleep more and their blood pressure goes down.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06642246 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 13–18 year-olds with a recent diagnosis of essential hypertension managed initially with lifestyle changes, who report ≤7.5 hours in bed per night, have internet or cellular access, and do not have a diagnosed sleep disorder.
Not a fit: Children with a diagnosed sleep disorder, those taking prescription antihypertensive or other blood-pressure–affecting medications, or those without reliable internet/phone access are unlikely to qualify or benefit from this intervention.
Why it matters
Potential benefit: If successful, this mobile sleep program could help teens increase nightly sleep and potentially lower blood pressure without starting medication.
How similar studies have performed: Prior research links sleep extension to blood pressure improvements in some populations, but using a mobile sleep-extension platform specifically in pediatric hypertension care is relatively novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insufficient Sleep, Hypertension