An interventional study of Family-informed intervention and Standard Clinical Care in Down Syndrome and Obstructive Sleep Apnea, sponsored by University of Miami. Completed at 3 sites in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 27 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria:
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Behavioral: Family-informed intervention
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Behavioral: Standard Clinical Care
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Percentage of Nights Adherent to PAP Therapy from Initiation to 6 Months
PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 6 months (T6). This is calculated as the number of nights meeting adherence criteria divided by the total number of nights during the participant's study participation period, multiplied by 100.
Time frame: 6 months
Number of Minutes of PAP Use on Nights Used
PAP adherence will be measured as the number of minutes of PAP use per night among nights with any recorded PAP use, calculated per participant from PAP initiation through the end of the 6-month intervention period.
Time frame: 6 months
Change in PedsQL Total Score (Quality of Life)
Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) total score. The PedsQL is a 5-point scale ranging from 0 to 4(0 = Never, 4 = Always), with higher scores indicating better quality of life.
Time frame: Baseline, 6 months, and 12 months
Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report Score
Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report. Scores are reported as standardized T-scores, which range from 30 to 120. Lower T-scores indicate better executive functioning, while higher T-scores indicate greater executive dysfunction.
Time frame: Baseline, 6 months, and 12 months
Percentage of Nights Adherent to PAP Therapy from Initiation to 12 Months
PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 12 months (T12). This is calculated as the number of nights meeting adherence criteria divided by the total number of days during the participant's study participation period, multiplied by 100.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Miami