[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06642246":3,"trial-entities:NCT06642246":186,"trial-summary:NCT06642246":189},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":42,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":72,"locations":75,"central_contacts":97,"overall_officials":100,"references":102,"see_also_links":185},"NCT06642246","24-022262","Sleep Promotion and Pediatric Hypertension","Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension","RECRUITING","2026-11","2026-08","2026-08-28","2026-02-16","Children's Hospital of Philadelphia","OTHER",false,"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.\n\nThe 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.\n\nThis 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.\n\nThe 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.",[19,20],"Insufficient Sleep","Hypertension",[19,20],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},10,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Arm 1",[36,39],{"measure":20,"description":37,"timeFrame":38},"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.","From baseline to approximately week 11",{"measure":40,"description":41,"timeFrame":38},"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.",[43,46,49,52],{"measure":44,"description":45,"timeFrame":38},"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.",{"measure":47,"description":48,"timeFrame":38},"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.",{"measure":50,"description":51,"timeFrame":38},"Change in daytime systolic\u002Fdiastolic 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\u002Fdiastolic 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\\].",{"measure":53,"description":54,"timeFrame":38},"Change in night time systolic\u002Fdiastolic blood pressures as measured by ABPM","Changes in nocturnal systolic and diastolic blood pressure from baseline. Measured variables include nighttime systolic\u002Fdiastolic 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\\].","ALL","13 Years","18 Years",{"inclusion":59,"exclusion":68,"raw_text":71},[60,61,62,63,64,65,66,67],"Speak, read and write in English.","Parental\u002Fguardian 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\u002Fguardian of an eligible child enrolled in the main study.","Speak, read, and write in English.",[69,70],"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:\n\n* Speak, read and write in English.\n* Parental\u002Fguardian permission (informed consent) and child assent.\n* Have a computer or a tablet computer with access to the Internet or own a smartphone with a data and text plan.\n* Parent reported sleep duration on school nights less than or equal to 7.5 hours.\n* Recently diagnosed with essential hypertension by Ambulatory Blood Pressure Monitoring (ABPM).\n* If taking over the counter sleep aides, willing to stop them over the course of the study.\n\nExclusion Criteria:\n\n* Any clinically diagnosed sleep disorder (e.g. sleep apnea) in the electronic health record and or regular use of prescribed sleep aide.\n* 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).\n\nInclusion Criteria for Parents\u002FLegal Guardians:\n\n* Be the parent\u002Fguardian of an eligible child enrolled in the main study.\n* Speak, read, and write in English.\n\nExclusion Criteria for Parents\u002FLegal Guardians:\n\n\\- Limited English proficiency",[73,74],"CHILD","ADULT",[76],{"facility":13,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":94},"Philadelphia","Pennsylvania","19146","United States",[82,87,91],{"name":83,"role":84,"phone":85,"email":86},"Jonathan Mitchell","CONTACT","267-426-1473","mitchellj2@chop.edu",{"name":88,"role":84,"phone":89,"email":90},"Abby Salem","215-590-2386","salema1@chop.edu",{"name":92,"role":93},"Jonathan Mitchell, PhD","PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},39.95238,-75.16362,[98,99],{"name":83,"role":84,"phone":85,"email":86},{"name":88,"role":84,"phone":89,"email":90},[101],{"name":92,"affiliation":13,"role":93},[103,107,110,113,116,119,122,125,128,131,134,137,140,143,146,149,152,155,158,161,164,167,170,173,176,179,182],{"pmid":104,"type":105,"citation":106},"12705565","BACKGROUND","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\u002F1467-8624.7402008.",{"pmid":108,"type":105,"citation":109},"27655459","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\u002Fjcsm.6338.",{"pmid":111,"type":105,"citation":112},"33601324","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\u002Fj.smrv.2021.101425. Epub 2021 Jan 19.",{"pmid":114,"type":105,"citation":115},"26551999","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\u002Fj.smrv.2015.08.006. Epub 2015 Sep 1.",{"pmid":117,"type":105,"citation":118},"36711634","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\u002F2023.01.04.23284151.",{"pmid":120,"type":105,"citation":121},"33981997","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\u002Fsleepadvances\u002Fzpab006. eCollection 2021.",{"pmid":123,"type":105,"citation":124},"7455683","Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126\u002Fscience.7455683.",{"pmid":126,"type":105,"citation":127},"29899015","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\u002FJAHA.118.009173.",{"pmid":129,"type":105,"citation":130},"26881417","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\u002FM15-1635. Epub 2016 Feb 16.",{"pmid":132,"type":105,"citation":133},"22431674","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\u002F0003-4819-156-6-201203200-00004.",{"pmid":135,"type":105,"citation":136},"24522623","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\u002Fs11606-014-2778-0. Epub 2014 Feb 13.",{"pmid":138,"type":105,"citation":139},"19066383","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\u002Fjama.2008.804.",{"pmid":141,"type":105,"citation":142},"25581921","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\u002Fsleep.4898.",{"pmid":144,"type":105,"citation":145},"29059263","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\u002Fjamapediatrics.2017.3233.",{"pmid":147,"type":105,"citation":148},"26547464","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\u002Fjama.2015.14850.",{"pmid":150,"type":105,"citation":151},"27641365","Mullins EN, Miller AL, Cherian SS, Lumeng JC, Wright KP Jr, Kurth S, Lebourgeois MK. Acute sleep restriction increases dietary intake in preschool-age children. J Sleep Res. 2017 Feb;26(1):48-54. doi: 10.1111\u002Fjsr.12450. Epub 2016 Sep 19.",{"pmid":153,"type":105,"citation":154},"25706861","Simon SL, Field J, Miller LE, DiFrancesco M, Beebe DW. Sweet\u002Fdessert foods are more appealing to adolescents after sleep restriction. PLoS One. 2015 Feb 23;10(2):e0115434. doi: 10.1371\u002Fjournal.pone.0115434. eCollection 2015.",{"pmid":156,"type":105,"citation":157},"18564072","Beebe DW, Fallone G, Godiwala N, Flanigan M, Martin D, Schaffner L, Amin R. Feasibility and behavioral effects of an at-home multi-night sleep restriction protocol for adolescents. J Child Psychol Psychiatry. 2008 Sep;49(9):915-23. doi: 10.1111\u002Fj.1469-7610.2008.01885.x. Epub 2008 Jun 28.",{"pmid":159,"type":105,"citation":160},"28934531","Van Dyk TR, Zhang N, Catlin PA, Cornist K, McAlister S, Whitacre C, Beebe DW. Feasibility and Emotional Impact of Experimentally Extending Sleep in Short-Sleeping Adolescents. Sleep. 2017 Sep 1;40(9). doi: 10.1093\u002Fsleep\u002Fzsx123.",{"pmid":162,"type":105,"citation":163},"29880148","Van Dyk TR, Krietsch KN, Saelens BE, Whitacre C, McAlister S, Beebe DW. Inducing more sleep on school nights reduces sedentary behavior without affecting physical activity in short-sleeping adolescents. Sleep Med. 2018 Jul;47:7-10. doi: 10.1016\u002Fj.sleep.2018.03.007. Epub 2018 Mar 29.",{"pmid":165,"type":105,"citation":166},"24190680","Hart CN, Carskadon MA, Considine RV, Fava JL, Lawton J, Raynor HA, Jelalian E, Owens J, Wing R. Changes in children's sleep duration on food intake, weight, and leptin. Pediatrics. 2013 Dec;132(6):e1473-80. doi: 10.1542\u002Fpeds.2013-1274. Epub 2013 Nov 4.",{"pmid":168,"type":105,"citation":169},"23729925","Beebe DW, Simon S, Summer S, Hemmer S, Strotman D, Dolan LM. Dietary intake following experimentally restricted sleep in adolescents. Sleep. 2013 Jun 1;36(6):827-34. doi: 10.5665\u002Fsleep.2704.",{"pmid":171,"type":105,"citation":172},"23071214","Gruber R, Cassoff J, Frenette S, Wiebe S, Carrier J. Impact of sleep extension and restriction on children's emotional lability and impulsivity. Pediatrics. 2012 Nov;130(5):e1155-61. doi: 10.1542\u002Fpeds.2012-0564. Epub 2012 Oct 15.",{"pmid":174,"type":105,"citation":175},"29717377","Fobian AD, Elliott L, Louie T. A Systematic Review of Sleep, Hypertension, and Cardiovascular Risk in Children and Adolescents. Curr Hypertens Rep. 2018 May 1;20(5):42. doi: 10.1007\u002Fs11906-018-0841-7.",{"pmid":177,"type":105,"citation":178},"23403646","Williams JA, Zimmerman FJ, Bell JF. Norms and trends of sleep time among US children and adolescents. JAMA Pediatr. 2013 Jan;167(1):55-60. doi: 10.1001\u002Fjamapediatrics.2013.423.",{"pmid":180,"type":105,"citation":181},"22331340","Matricciani LA, Olds TS, Blunden S, Rigney G, Williams MT. Never enough sleep: a brief history of sleep recommendations for children. Pediatrics. 2012 Mar;129(3):548-56. doi: 10.1542\u002Fpeds.2011-2039. Epub 2012 Feb 13.",{"pmid":183,"type":105,"citation":184},"27707447","Paruthi S, Brooks LJ, D'Ambrosio C, Hall WA, Kotagal S, Lloyd RM, Malow BA, Maski K, Nichols C, Quan SF, Rosen CL, Troester MM, Wise MS. Consensus Statement of the American Academy of Sleep Medicine on the Recommended Amount of Sleep for Healthy Children: Methodology and Discussion. J Clin Sleep Med. 2016 Nov 15;12(11):1549-1561. doi: 10.5664\u002Fjcsm.6288.",[],{"nct_id":4,"conditions":187,"biomarkers":188},[20,19],[],{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is a home-based study involving 10 participants (5 parent-child pairs). It is an interventional study, meaning participants will receive a specific intervention.","completed","Sleep Promotion for Teen Hypertension","This study is looking at a new way to help teenagers (ages 13-18) with high blood pressure (hypertension) get more sleep. The study will test a program that encourages parent-child pairs to meet a sleep goal. This program uses text messages with sleep tips and a virtual account where money is deducted if sleep goals aren't met. Researchers want to see if this approach can increase how long teens sleep and lower their blood pressure. To join, you should speak English, have internet access or a smartphone, and typically sleep 7.5 hours or less on school nights. The study is currently unclear on its recruitment status.","Your blood pressure and sleep duration will be measured from the start of the study until approximately week 11.",106,"During a 7-week intervention, you and your child will receive sleep guidance text messages and weekly performance updates. You will also use a sleep tracker throughout the study, which lasts about 11 weeks.","Not stated in the trial record.",[],"v2"]