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Family-Informed Intervention for Obstructive Sleep Apnea in Children with Down Syndrome

N/A
Recruiting
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Naive to PAP treatment
Children are able to cooperate with testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, and 12 months
Awards & highlights

Study Summary

This trial will compare a family-informed intervention to standard care for children with obstructive sleep apnea and Down Syndrome, to see if the intervention is more effective over a 12 month period.

Who is the study for?
This trial is for children aged 6-18 with Down Syndrome and obstructive sleep apnea who haven't used PAP treatment before. They must be able to do tests and have a clinical referral for PAP. It's not for kids in foster care, those treated with PAP already, or with major illnesses like leukemia or severe heart disease.Check my eligibility
What is being tested?
The study compares the effectiveness of a family-informed intervention versus standard clinical care over twelve months in treating sleep apnea in children with Down Syndrome.See study design
What are the potential side effects?
Since this trial involves non-medical interventions (family-informed support vs standard care), there are no direct medical side effects listed; however, discomfort or resistance to therapy could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never received PAP treatment.
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My child can follow instructions for tests.
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I am between 6 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of PAP adherence in children with DS and OSAS on patient-centered outcomes and family-relevant outcomes identified during the R61 phase of this research
Effect of PAP adherence on quality of life and neurobehavioral outcomes
Efficacy of CON in promoting PAP adherence
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Family-informed intervention (INT)Active Control1 Intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Group II: Standard Clinical CareActive Control1 Intervention
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
900 Previous Clinical Trials
409,846 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,510 Total Patients Enrolled
University of PennsylvaniaOTHER
2,002 Previous Clinical Trials
42,880,783 Total Patients Enrolled

Media Library

Family-informed intervention Clinical Trial Eligibility Overview. Trial Name: NCT04132999 — N/A
Obstructive Sleep Apnea Research Study Groups: Family-informed intervention (INT), Standard Clinical Care
Obstructive Sleep Apnea Clinical Trial 2023: Family-informed intervention Highlights & Side Effects. Trial Name: NCT04132999 — N/A
Family-informed intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04132999 — N/A

Frequently Asked Questions

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

Are there any vacancies for prospective participants in this research endeavor?

"Yes, the data on clinicaltrials.gov shows that this medical trial is actively looking for participants. The study was originally launched on March 1st 2021 and its details were revised most recently on March 15th 2022."

Answered by AI

Is it possible to take part in this clinical research study?

"This medical trial is seeking 86 participants that are between the ages of 6 and 18, all with a diagnosis of Down syndrome."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative, clinicaltrials.gov provides evidence that this medical trial is seeking participants as of now - it was initially posted on March 1st 2021 and updated lastly on the 15th day of March 2022. Around 86 individuals need to be recruited from 2 distinct sites."

Answered by AI

Does this research project accept volunteers over the age of 35?

"This clinical trial's criteria for participation states that the youngest prospective patient must be 6 years old while the eldest should not exceed 18."

Answered by AI

Who else is applying?

What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PAP for Children With DS and OSAS
2021. "PAP for Children With DS and OSAS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04132999.
All > Down Syndrome
~8 spots leftby Sep 2024
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