Sleep Promotion and Pediatric Hypertension
Recruiting · NCT06642246 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Intervention
What this trial is about
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.
Who can take part
Age range
13 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States