An interventional study of Intervention in Insufficient Sleep and Hypertension, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for Parents/Legal Guardians:
Exclusion Criteria for Parents/Legal Guardians:
- Limited English proficiency
Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.
Behavioral: Intervention
During 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.
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 11
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 11
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 11
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 11
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 11
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 11
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia