Clinical trial NCT04132999: PAP for Children With DS and OSAS
Official title: Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Obstructive Sleep Apnea
Keywords: Down Syndrome
Obstructive Sleep Apnea
PAP
Positive Airway Pressure
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Children's Hospital Medical Center, Cincinnati
name: University of Pennsylvania
First posted: 2019-10-21
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: family-informed intervention (INT) vs standard clinical care (CON).
Primary purpose: TREATMENT

Brief summary: Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.

Detailed description: Evaluate the effect of PAP adherence on quality of life, neurobehavioral, and healthcare utilization in children with DS and OSAS. It is being hypothesized that, irrespective of study arm, increased PAP adherence will be associated with better quality of life, neurobehavioral, and healthcare utilization outcomes.

Evaluate the 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. It is being hypothesized that irrespective of study arm, increased PAP adherence will be associated with better patient-centered outcomes, and family-relevant outcomes identified during the first year of this research.

Determine the efficacy of INT vs. CON in promoting PAP adherence. It is being hypothesized that that children receiving INT will show significantly increased objectively-measured PAP adherence at 6 months compared with those receiving CON (Aim 4A). As a secondary aim (4B), it will be evaluated whether the improved adherence is maintained over 12 months. It is being hypothesized that participants initially randomized to the INT arm will have better adherence at 12 months compared to those in the CON arm.

Use mixed methods during the randomized controlled trial to identify family perceptions, such as empowerment and self-efficacy, regarding PAP use in youth with OSAS and DS. It is being hypothesized that INT-PAP will be associated with more positive perceptions compared to CON.

Eligibility 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.

Primary outcomes:
measure: Effect of PAP adherence on quality of life and neurobehavioral outcomes
timeFrame: Baseline, 6 months, and 12 months
measure: Efficacy of INT-PAP in promoting PAP adherence
timeFrame: 6 months, and 12 months
measure: Efficacy of CON in promoting PAP adherence
timeFrame: 6 months, and 12 months
measure: 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
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References: