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Sleep Navigation for Pediatric Sleep Apnea

N/A
Waitlist Available
Led By Ariel Williamson, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregiver is 18 years of age or older
Child is between 2 years and 17 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will help researchers understand how well a Sleep Navigation program and clinical decision support can help manage pediatric sleep-disordered breathing.

Who is the study for?
This trial is for children aged 2-17 with sleep-disordered breathing who snore frequently, receiving care at specific CHOP network sites. Their caregivers must be English-speaking legal guardians over 18 years old. Children from non-participating sites or those with non-compliant guardians are excluded.Check my eligibility
What is being tested?
The study tests a program combining clinical decision support (CDS) and Sleep Navigation against CDS alone to improve management of pediatric sleep-disordered breathing from primary to specialty care.See study design
What are the potential side effects?
Since this trial involves decision support systems and navigational programs rather than medications, traditional side effects are not applicable. However, there may be indirect effects on the child's and family's routine or stress levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My caregiver is at least 18 years old.
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My child is between 2 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the CDS Tool
Acceptability of the Sleep Navigation program (Multicultural Therapy Competency Inventory)
Acceptability of the Sleep Navigation program (Treatment Evaluation Inventory-Short Form)
+4 more
Secondary outcome measures
Caregiver knowledge of Sleep Disordered Breathing (SDB)
Child SDB symptoms: Pediatric Sleep Questionnaire
Child obstructive sleep apnea symptoms
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep Navigation groupExperimental Treatment1 Intervention
Caregiver-child dyads in this study arm (intervention condition) will participate in the Sleep Navigation program.
Group II: CDS-only groupExperimental Treatment1 Intervention
Caregiver-child dyads in this study arm (control group) will not participate in the Sleep Navigation program, but will be directed to follow up with their primary care clinician as needed.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
705 Previous Clinical Trials
8,571,407 Total Patients Enrolled
Ariel Williamson, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
2 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~13 spots leftby Mar 2025