PAP for Children With DS and OSAS

Obstructive Sleep Apnea Clinical Trial

Official title:

Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132999
• Other study ID #: 20230780
• Secondary ID: R61HL151253-01R3
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Down Syndrome
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Behavioral:
• Family-informed intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
• Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Miami	Miami	Florida
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Miami	Children's Hospital Medical Center, Cincinnati, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of PAP adherence on quality of life and neurobehavioral outcomes	PedsQL score and measures of executive functioning will be compared in the 2 groups. PedsQL is a 5-point scale ranging from 0-4 (0 = Never, 4 = Always).	Baseline, 6 months, and 12 months
Primary	Efficacy of INT-PAP in promoting PAP adherence	Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.	6 months, and 12 months
Primary	Efficacy of CON in promoting PAP adherence	Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.	6 months, and 12 months
Primary	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	Patient-centered outcomes and family-relevant outcomes - identified during the R61 phase of the study (Stage 1) - will be compared between the intervention and control groups. These are qualitative measures, and require interviews and further analysis to be established.	Baseline, 6 months, and 12 months