PAP for Children With DS and OSAS

University of Miami

Status: Enrolling

Conditions: Down Syndrome; Obstructive Sleep Apnea

Treatments: Behavioral: Standard Clinical Care; Behavioral: Family-informed intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04132999

20230780

R61HL151253-01 (U.S. NIH Grant/Contract)

R33HL151253 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups

Family-informed intervention (INT)

Active Comparator group

Description:

Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.

Treatment:

Behavioral: Family-informed intervention

Standard Clinical Care

Active Comparator group

Description:

Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Treatment:

Behavioral: Standard Clinical Care