Evaluating PAP treatment for children with Down Syndrome and sleep apnea
Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
This study is testing whether a new family-focused approach can help children with Down Syndrome and sleep apnea stick to their PAP therapy better than regular care, to see if it improves their quality of life and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT04132999 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a family-informed intervention compared to standard clinical care in promoting adherence to Positive Airway Pressure (PAP) therapy in children aged 6-18 with Down Syndrome and obstructive sleep apnea. Over a twelve-month period, the study will evaluate the impact of PAP adherence on quality of life, neurobehavioral outcomes, and healthcare utilization. The research will utilize mixed methods to gather insights on family perceptions and empowerment regarding PAP use, hypothesizing that increased adherence will lead to improved outcomes regardless of the intervention type.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-18 years with Down Syndrome who are newly referred for PAP treatment for obstructive sleep apnea.
Not a fit: Patients with major illnesses or those who have previously been treated with PAP may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and health outcomes for children with Down Syndrome and obstructive sleep apnea through improved adherence to PAP therapy.
How similar studies have performed: Other studies have shown promise in improving adherence to PAP therapy through family-centered approaches, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical referral for PAP initiation to treat OSAS * Ages 6-18 years * Children are able to cooperate with testing * Naive to PAP treatment Exclusion Criteria: * Major illnesses, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant. * Family planning to move out of the city within the next year * Children in foster care * Child with previously treated with PAP * Caregivers who do not speak English well enough to complete behavioral and performance measures.
Where this trial is running
Miami, Florida and 2 other locations
- University of Miami — Miami, Florida, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.