Sleep Promotion and Pediatric Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Intervention
BehavioralDuring 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to approximately week 112
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.
Time frame
From baseline to approximately week 11Secondary outcomes
1
Change in sleep tracker estimated sleep duration
Change in sleep tracker estimated sleep duration will be measured from baseline (operationalized as the average hours per night 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.
Time frame
From baseline to approximately week 112
Changes in sleep disturbance score measured by the Patient-Reported Outcome Measurement System (PROMIS) tool
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) item bank for pediatric sleep. This validated survey generates a composite sleep disturbance T-score based on items related to sleep onset, sleep continuity and sleep quality in the past week. Higher T-scores indicates poorer sleep quality.
Time frame
From baseline to approximately week 113
Change in daytime systolic/diastolic blood pressures as measured by Ambulatory Blood Pressure Monitoring (ABPM)
Changes in daytime systolic and diastolic blood pressure from baseline. Measured variables include daytime systolic/diastolic mean BP, BP index (calculated by dividing the average BP of the participant by the sex and height specific 95th percentiles for systolic and diastolic BP\].
Time frame
From baseline to approximately week 114
Change in night time systolic/diastolic blood pressures as measured by ABPM
Changes in nocturnal systolic and diastolic blood pressure from baseline. Measured variables include nighttime systolic/diastolic mean BP, percent nocturnal dipping, BP index (calculated by dividing the average BP of the participant by the sex and height specific 95th percentiles for systolic and diastolic BP\].
Time frame
From baseline to approximately week 11Sponsors and contacts
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Source ClinicalTrials.gov