Healthy Sleep for Children With Down Syndrome (HELP-DS)
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|ClinicalTrials.gov Identifier: NCT03922165|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment|
|Down Syndrome Sleep Disordered Breathing||Procedure: Adenotonsillectomy|
Down syndrome (DS) is associated with a wide range of neurobehavioral and physical morbidities. Obstructive sleep apnea (OSA) is prevalent in children with DS and causes a myriad of physiological stresses that may exacerbate neurobehavioral and cardiac morbidities. Improving sleep health thus provides a modifiable intervention target for improving behavior, cognition, quality of life, and physical health of children with DS. However, critical knowledge gaps limit the adoption and implementation of effective OSA interventions, resulting in practice variability and suboptimal treatment of OSA across the spectrum of DS. In particular, it is in unclear how to select candidates likely to benefit from adenotonsillectomy (AT) and how to utilize information from polysomnographic, clinical, and demographic parameters to predict children most likely to benefit from AT compared to alternative treatments or to watchful waiting. The goal of this study is to collect the necessary data to plan and execute a future pivotal RCT of the role of OSA treatment in the care of children with DS. This study will provide critical information on the methodological approaches for conducting such a randomized controlled clinical trial (RCT), informing the appropriate recruitment strategies, patient population and outcome measures for a future clinical trial. The investigators will leverage expertise in pediatric sleep medicine, clinical trials, neuropsychology, and DS as well as the PATS clinical trials infrastructure to catalyze a new DS clinical research initiative. Our proposed next steps are to enroll in an observational study at active PATS centers 50 children with DS who are referred for clinically indicated evaluation and treatment of OSA. At baseline and 6 months following AT, these children will undergo systematic assessments of sleep, behavior, cognition, daytime functioning, and quality of life, generating key data to inform the design of a later pivotal RCT.
Healthy Sleep for Children with Down Syndrome (HELP-DS) intends to take advantage of a successful collaboration of leaders in sleep medicine, otolaryngology and clinical trials to efficiently leverage experiences from the The Childhood Adenotonsillectomy Trial (CHAT) as well as the current resources of the PATS trial to collect data for the evaluation of key questions needed to design a future RCT, including approaches related to the selection of participating sites, the patient population to receive the intervention, and outcome measurements.
The primary objective of HELP-DS to determine the feasibility of recruiting and retaining individuals in an observational study of AT across multiple clinical sites.
Secondary objectives are:
- Evaluate the feasibility of collecting a range of baseline and outcome data, and specifically the ability of children to perform neurobehavioral assessments (GoNoGo, pegboard task).
- Understand issues related to patient preference, equipoise, and barriers to treatment. The investigators will track how many children referred for AT actually undergo surgery, the time interval between referral and surgery, other interventions pursued, and factors such as insurance, socio-economic factors, and cultural norms, that associate with family-decision making.
- Examine the consistency and completeness of Healthcare Utilization (HCU) data extracted across our sites, describing differences by recruitment site, health, system characteristics, insurance-related factors, etc. The investigators will estimate incidence rates of HCU events for hospital admissions, emergency department/unscheduled office visits, specialty consultations and medication use during the 6 months following surgery and compare rates to those for the year prior to surgery.
These aims have substantial public health significance given the high morbidity of Down syndrome and sleep-disordered breathing in children.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Healthy Sleep for Children With Down Syndrome|
|Actual Study Start Date :||May 22, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
DS peds eligible for Adenotonsillectomy
Dyads of caregivers and children with DS aged 3-13 years diagnosed with SDB and referred for treatment with adenotonsillectomy.
Routine AT per clinical care.
- % enrolled/approached [ Time Frame: 1 year ]Percentage of families approached for participation that sign informed consent to participate.
- % retained/enrolled [ Time Frame: 1 year ]Percentage of consented families that completed study participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922165
|Contact: Michael G Morricalemail@example.com|
|Contact: Jessie P Bakker, PhDfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Health System||Not yet recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Libby Hobson 734-936-4817 email@example.com|
|Principal Investigator: Ronald D Chervin, MD|
|Sub-Investigator: Fauziya Hassan, MBBS, MS|
|Sub-Investigator: Susan L Garetz, MD|
|Sub-Investigator: David A Zopf, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Suzanna Hicks 513-636-4944 firstname.lastname@example.org|
|Principal Investigator: Raouf S Amin, MD|
|Sub-Investigator: Stacey L Ishman, MD, MPH|
|University Hospitals-Case Medical Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Heather Rogers 216-368-0475 email@example.com|
|Principal Investigator: Carol L Rosen, MD|
|Sub-Investigator: Kristie R Ross, MD|
|Sub-Investigator: Hudson G Taylor, PhD|
|Sub-Investigator: Jay Shah, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Laurie Rosenthal 215-590-9184 firstname.lastname@example.org|
|Principal Investigator: Ignacio E Tapia, MD|
|Sub-Investigator: Jerilynn Radcliffe, PhD|
|Sub-Investigator: Lisa M Elden, MD MS FRCSC|
|United States, Texas|
|University of Texas Southwestern Medical Center||Not yet recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Lauren Plummer 214-456-2269 Lauren.Plummer@childrens.com|
|Principal Investigator: Ronald B Mitchell, MD|
|Sub-Investigator: Kamal M Naqvi, MD|
|United States, Virginia|
|Children's Hospital of the King's Daughters||Not yet recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Laura Stone 757-388-6238 email@example.com|
|Principal Investigator: Christina M Baldassari, MD|
|Sub-Investigator: Michael J Strunc, MD|
|Sub-Investigator: Jennifer L Wiebke, MD|
|Principal Investigator:||Susan S Redline, MD, MPH||Brigham and Women's Hospital|
|Principal Investigator:||Rui Wang, PhD||Brigham and Women's Hospital|
|Principal Investigator:||Susan L Furth, Md, PhD||Children's Hospital of Philadelphia|