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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL151253 | U.S. NIH Grant/Contract | View source | |
| R33HL151253 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-informed intervention (INT) | Active Comparator | Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team. |
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| Standard Clinical Care | Active Comparator | Support which is given as part of the standard clinical care for patients who are currently prescribed PAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-informed intervention | Behavioral | Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Change in PedsQL Total Score (Quality of Life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio E. Tapia, M.D., M.S. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41285506 | Derived | Xanthopoulos MS, Byars K, Meinzen-Derr J, Ebensen A, Xiao R, Heubi C, Gurbani NS, Ishman SL, Bradford R, Hicks S, Redline S, Tapia IE. Standard medical care versus enhanced interdisciplinary care for implementation of positive airway pressure in youth with Down syndrome: a randomised controlled trial protocol. BMJ Open. 2025 Nov 23;15(11):e110990. doi: 10.1136/bmjopen-2025-110990. |
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| University of Pennsylvania |
| OTHER |
family-informed intervention (INT) vs standard clinical care (CON).
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| Standard Clinical Care | Behavioral | Support which is given as part of the standard clinical care for patients who are currently prescribed PAP. |
|
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. |
| 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. | 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. | 12 months |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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