Clinical trial NCT06642246: Sleep Promotion and Pediatric Hypertension
Official title: Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insufficient Sleep
Hypertension
Keywords: Insufficient Sleep
Hypertension
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Hypertension
timeFrame: From baseline to approximately week 11
measure: Change in sleep tracker estimated weeknight sleep duration
timeFrame: From baseline to approximately week 11
Secondary outcomes:
measure: Change in sleep tracker estimated sleep duration
timeFrame: From baseline to approximately week 11
measure: Changes in sleep disturbance score measured by the Patient-Reported Outcome Measurement System (PROMIS) tool
timeFrame: From baseline to approximately week 11
measure: Change in daytime systolic/diastolic blood pressures as measured by Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From baseline to approximately week 11
measure: Change in night time systolic/diastolic blood pressures as measured by ABPM
timeFrame: From baseline to approximately week 11
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jonathan Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
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