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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

Must not have

Caregivers who do not speak English well enough to complete behavioral and performance measures

Child with previously treated with PAP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a caregiver and I do not speak English well enough for medical assessments.

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My child was previously treated with PAP.

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I do not have major illnesses like leukemia or severe heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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