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
Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.
Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 118th largest by planned enrollment of the 127 interventional ones, is one of 8 that started in 2026, is one of 104 with no phase, reaches primary completion later than 16 of the 34 other live ones, and was the 134th registered.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →30 of the 146 studies in Sleep Deprivation with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.
This study: 13 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 8 started in 2026.
Median enrollment 56 across the 127 interventional studies, 64 across the 19 observational. Of the 106 that completed or were terminated, 27 (25%) have results posted.
13 of 146 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 5 studies filed under Sleep Deprivation — fewer than ten, so there is no comparison to draw.
7 of the studies in Sleep Deprivation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06642246Children's Hospital of PhiladelphiaSleep Promotion and Pediatric Hypertension | 2026-11 |
| NCT06336525Brigham and Women's HospitalAdult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. | 2027-01-31 |
| NCT05393830Beth Israel Deaconess Medical CenterThe Effect of Sleep Loss on Emotion Regulation | 2027-04-01 |
| NCT05703347Children's Hospital of PhiladelphiaOptimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children | 2027-06 |
| NCT02945501U.S. Army Medical Research and Development CommandTranscranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep | 2027-06 |
Among the 146 studies in Sleep Deprivation with a site in United States, from their registry updates:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Feb 2026 (actual). Primary completion is estimated for Nov 2026, 9 months after the start.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 9 months is below that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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