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Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 2)

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ClinicalTrials.gov Identifier: NCT04132999
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 21, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
  • Effect of PAP adherence on quality of life and neurobehavioral outcomes [ Time Frame: Baseline, 6 months, and 12 months ]
    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).
  • Efficacy of INT-PAP in promoting PAP adherence [ Time Frame: 6 months, and 12 months ]
    Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
  • Efficacy of CON in promoting PAP adherence [ Time Frame: 6 months, and 12 months ]
    Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
  • 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 [ Time Frame: Baseline, 6 months, and 12 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Change in PAP adherence will be associated with improvements of neurobehavioral outcomes measured by parent report of the Pediatric Quality of Life Inventory. [ Time Frame: 6 months ]
  • Change in PAP adherence measured by average nights used [ Time Frame: 6 months ]
  • Family-informed intervention will show significantly increased PAP adherence measured in average nights used by an increase of 7.5 points in the Behavioral Rating Inventory of Executive Function (BRIEF) compared to standard clinical care [ Time Frame: 6 months ]
  • More positive perceptions of PAP will be associated with family-informed intervention compared to standard clinical care measured by parent report [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT04132999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
Children who received family-informed intervention will continue their improved adherence for 12 months measured by average nights used [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 2)
Official Title  ICMJE Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
family-informed intervention (INT) vs standard clinical care (CON).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Down Syndrome
  • Obstructive Sleep Apnea
Intervention  ICMJE
  • Behavioral: Family-informed intervention
    Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
  • Behavioral: Standard Clinical Care
    Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Study Arms  ICMJE
  • Active Comparator: Family-informed intervention (INT)
    Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
    Intervention: Behavioral: Family-informed intervention
  • Active Comparator: Standard Clinical Care
    Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
    Intervention: Behavioral: Standard Clinical Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2019)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04132999
Other Study ID Numbers  ICMJE R61HL15125301 -- Stage 2
R61HL151253-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Children's Hospital Medical Center, Cincinnati
  • University of Pennsylvania
Investigators  ICMJE Not Provided
PRS Account Children's Hospital of Philadelphia
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP