This trial will help researchers understand how well a Sleep Navigation program and clinical decision support can help manage pediatric sleep-disordered breathing.
- Sleep Apnea
- Obstructive Sleep Apnea
8 Primary · 9 Secondary · Reporting Duration: through study completion, an average of 1 year
Awards & Highlights
1 Treatment Group
Sleep Navigation group
1 of 1
470 Total Participants · 1 Treatment Group
Primary Treatment: CDS with Sleep Navigation · No Placebo Group · N/A
Who is running the clinical trial?
Age 2 - 17 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Rosen, Carol L., Emma K. Larkin, H.Lester Kirchner, Judith L. Emancipator, Sarah F. Bivins, Susan A. Surovec, Richard J. Martin, and Susan Redline. 2003. “Prevalence and Risk Factors for Sleep-disordered Breathing in 8- to 11-year-old Children: Association with Race and Prematurity”. The Journal of Pediatrics. Elsevier BV. doi:10.1067/mpd.2003.28.
- Bonuck, Karen A., Ronald D. Chervin, Timothy J. Cole, Alan Emond, John Henderson, Linzhi Xu, and Katherine Freeman. 2011. “Prevalence and Persistence of Sleep Disordered Breathing Symptoms in Young Children: A 6-year Population-based Cohort Study”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.1118.
- Boss, Emily F., David F. Smith, and Stacey L. Ishman. 2011. “Racial/ethnic and Socioeconomic Disparities in the Diagnosis and Treatment of Sleep-disordered Breathing in Children”. International Journal of Pediatric Otorhinolaryngology. Elsevier BV. doi:10.1016/j.ijporl.2010.11.006.
- Meltzer, Lisa J., Melissa R. Plaufcan, Jocelyn H. Thomas, and Jodi A. Mindell. 2014. “Sleep Problems and Sleep Disorders in Pediatric Primary Care: Treatment Recommendations, Persistence, and Health Care Utilization”. Journal of Clinical Sleep Medicine. American Academy of Sleep Medicine (AASM). doi:10.5664/jcsm.3620.
- Archbold, Kristen Hedger, Kenneth J. Pituch, Parviz Panahi, and Ronald D. Chervin. 2002. “Symptoms of Sleep Disturbances Among Children at Two General Pediatric Clinics”. The Journal of Pediatrics. Elsevier BV. doi:10.1067/mpd.2002.119990.
- Marcus, Carole L., Lee Jay Brooks, Kari A. Draper, David Gozal, Ann Carol Halbower, Jacqueline Jones, Michael S. Schechter, et al.. 2012. “Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2012-1671.
- Archbold KH, Pituch KJ, Panahi P, Chervin RD. Symptoms of sleep disturbances among children at two general pediatric clinics. J Pediatr. 2002 Jan;140(1):97-102. doi: 10.1067/mpd.2002.119990.
- Rosen CL, Larkin EK, Kirchner HL, Emancipator JL, Bivins SF, Surovec SA, Martin RJ, Redline S. Prevalence and risk factors for sleep-disordered breathing in 8- to 11-year-old children: association with race and prematurity. J Pediatr. 2003 Apr;142(4):383-9. doi: 10.1067/mpd.2003.28.
- Boss EF, Smith DF, Ishman SL. Racial/ethnic and socioeconomic disparities in the diagnosis and treatment of sleep-disordered breathing in children. Int J Pediatr Otorhinolaryngol. 2011 Mar;75(3):299-307. doi: 10.1016/j.ijporl.2010.11.006. Epub 2011 Feb 4.
- 2022. "Efficacy of Clinical Decision Support and Sleep Navigation (Sleep PASS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05353998.
Frequently Asked Questions
Is it feasible for me to take part in this medical experiment?
"This scientific investigation is recruiting 470 young individuals from the ages of 2 to 17 that suffer from sleeping issues. The required qualifications are as follows: between two and seventeen years of age, a positive response on their sleep screener assessment at CHOP's primary care network, parental or legal guardian permission with possible child assent if needed, eighteen-years-old English speaker parent or guardina caregiver participant who also receives well care in Cobbs Creek/Karabots CHOP primary care networks." - Anonymous Online Contributor
Does this trial accept volunteers under the age of 30?
"The requirements for this trial specify that eligible participants are aged between 2 and 17. Furthermore, there are 82 trials available specifically for minors, with 387 studies dedicated to patients over 65 years of age." - Anonymous Online Contributor
What are the specific objectives of this experimental endeavor?
"Over the course of 8 months, this trial strives to assess the acceptability of a CDS Tool. Secondary objectives comprise evaluating Sleep specialty care referral rates, Child sleep habits through use of the Brief Child Sleep Questionnaire (BCSQ), and measuring Child obstructive sleep apnea symptoms with an OSA-18 questionnaire." - Anonymous Online Contributor
Is there still capacity to take on new participants in this research?
"All data present on clinicaltrials.gov signals that this research project is actively recruiting patients. It was first shared on August 1st 2022, and the information has been updated as recently as August 17th 2022." - Anonymous Online Contributor
What is the upper cap of subjects involved in this experiment?
"Affirmative. According to clinicaltrials.gov, this particular trial is actively recruiting participants as of August 17th 2022. This medical experiment was initially posted on August 1st and requires 470 patients from one location in order to be completed." - Anonymous Online Contributor