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Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)

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ClinicalTrials.gov Identifier: NCT04124471
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE August 2, 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)		 PAP Acceptability [ Time Frame: one day ]
Perform qualitative interviews to determine factors that impact PAP acceptability and use in youth with DS and OSAS, and identify family-centered outcomes to inform the development of an intervention to improve adherence to CPAP
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04124471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 1)
Official Title  ICMJE Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)
Brief Summary The primary objective of this study is to identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of OSAS with PAP in children with DS.
Detailed Description This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS treated with PAP and their children will be enrolled. The study comprises one 30-minute open-ended semi-structured interview per caregiver. The duration of the interview is approximate. It will last up to 30 minutes as some families may want to include more details.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Down Syndrome
  • Obstructive Sleep Apnea
Intervention  ICMJE Behavioral: Open-ended semi-structured interviews
Semi-structured interviews will explore such key constructs as knowledge/belief about OSAS and PAP therapy, routines and resources that promote or limit PAP use, barriers, self-efficacy, and communication and attitudes about PAP. The interviews will be performed with the parent and that they will be audio-recorded.
Study Arms  ICMJE Not Provided
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria -- Patients

  • Children with DS and OSAS treated with PAP for at least 6 months
  • Children aged between 6 and 17.5 years
  • English proficiency

Inclusion Criteria -- Caregivers

  • Parent or legal guardian of an eligible patient subject
  • English proficiency
  • Must live with the patient subject at least 4 nights of the week

Exclusion Criteria -- Patients

  • In foster care
  • Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders

Exclusion Criteria -- Caregivers

  • Foster parent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ignacio E Tapia, MD (267) 426-5842 tapia@email.chop.edu
Contact: Ruth Bradford (267) 246-5747 bradford@email.chop.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124471
Other Study ID Numbers  ICMJE 19-016222
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)
  • University of Pennsylvania
  • Children's Hospital Medical Center, Cincinnati
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