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Insufficient SleepNCT06642246

Sleep Promotion and Pediatric Hypertension

A study testing Intervention in people with Insufficient Sleep and Hypertension, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Insufficient Sleep, Hypertension
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
16 Feb 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • Be the parent/guardian of an eligible child enrolled in the main study.
  • Speak, read, and write in English.

Who cannot join

  • 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).
  • Limited English proficiency

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Mitchell contact

267-426-1473

mitchellj2@chop.edu

United States1 site, 1 recruiting
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

    Jonathan Mitchell, 267-426-1473, mitchellj2@chop.edu

    Abby Salem, 215-590-2386, salema1@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension

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.

Read the 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.

Being tested
Intervention
Keywords
Insufficient Sleep, Hypertension
Medical subject headings
Sleep Deprivation, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.

Study groups in NCT06642246
Study groupRoleWhat they receive
Arm 1ExperimentalSleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.
Receives: Behavioral: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to approximately week 11

  2. 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.

    Measured: From baseline to approximately week 11

Secondary outcomes (4)
  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.

    Measured: From baseline to approximately week 11

  2. 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.

    Measured: From baseline to approximately week 11

  3. 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].

    Measured: From baseline to approximately week 11

  4. 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].

    Measured: From baseline to approximately week 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start16 Feb 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06642246
Sponsor's protocol ID
24-022262
Status last verified
Aug 2026
First submitted
4 Oct 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sadeh A, Gruber R, Raviv A. The effects of sleep restriction and extension on school-age children: what a difference an hour makes. Child Dev. 2003 Mar-Apr;74(2):444-55. doi: 10.1111/1467-8624.7402008.

    PubMed 12705565
  • Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.

    PubMed 27655459
  • Meltzer LJ, Williamson AA, Mindell JA. Pediatric sleep health: It matters, and so does how we define it. Sleep Med Rev. 2021 Jun;57:101425. doi: 10.1016/j.smrv.2021.101425. Epub 2021 Jan 19.

    PubMed 33601324
  • Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.

    PubMed 26551999
  • Mitchell JA, Morales KH, Williamson AA, Jawahar A, Juste L, Vajravelu ME, Zemel BS, Dinges DF, Fiks AG. Promoting Sleep Duration in the Pediatric Setting Using a Mobile Health Platform: A Randomized Optimization Trial. medRxiv [Preprint]. 2023 Jan 5:2023.01.04.23284151. doi: 10.1101/2023.01.04.23284151.

    PubMed 36711634
  • Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.

    PubMed 33981997
  • Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.

    PubMed 7455683
  • Chokshi NP, Adusumalli S, Small DS, Morris A, Feingold J, Ha YP, Lynch MD, Rareshide CAL, Hilbert V, Patel MS. Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial. J Am Heart Assoc. 2018 Jun 13;7(12):e009173. doi: 10.1161/JAHA.118.009173.

    PubMed 29899015
  • Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.

    PubMed 26881417
  • Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.

    PubMed 22431674
  • Sen AP, Sewell TB, Riley EB, Stearman B, Bellamy SL, Hu MF, Tao Y, Zhu J, Park JD, Loewenstein G, Asch DA, Volpp KG. Financial incentives for home-based health monitoring: a randomized controlled trial. J Gen Intern Med. 2014 May;29(5):770-7. doi: 10.1007/s11606-014-2778-0. Epub 2014 Feb 13.

    PubMed 24522623
  • Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.

    PubMed 19066383
  • Kuna ST, Shuttleworth D, Chi L, Schutte-Rodin S, Friedman E, Guo H, Dhand S, Yang L, Zhu J, Bellamy SL, Volpp KG, Asch DA. Web-Based Access to Positive Airway Pressure Usage with or without an Initial Financial Incentive Improves Treatment Use in Patients with Obstructive Sleep Apnea. Sleep. 2015 Aug 1;38(8):1229-36. doi: 10.5665/sleep.4898.

    PubMed 25581921
  • Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233.

    PubMed 29059263
  • Asch DA, Troxel AB, Stewart WF, Sequist TD, Jones JB, Hirsch AG, Hoffer K, Zhu J, Wang W, Hodlofski A, Frasch AB, Weiner MG, Finnerty DD, Rosenthal MB, Gangemi K, Volpp KG. Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels: A Randomized Clinical Trial. JAMA. 2015 Nov 10;314(18):1926-35. doi: 10.1001/jama.2015.14850.

    PubMed 26547464

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Insufficient Sleep and Hypertension, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Mitchell (267-426-1473, mitchellj2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypertension (time frame: From baseline to approximately week 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06642246, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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