Trial Outcomes & Findings for Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1) (NCT NCT04124471)

NCT ID: NCT04124471

Last Updated: 2023-04-25

Results Overview

PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: one day
• Results posted on: 2023-04-25

Participant Flow

Participant milestones

Measure	Interview Completion The number of participants who completed the interview process.
Overall Study STARTED	42
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Interview Completion The number of participants who completed the interview process.
Overall Study screen failure	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Interview Completion n=41 Participants The number of participants who completed the interview process.
Age, Customized Age at screening	12.6 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male All Sites · Female	28 Participants n=5 Participants
Sex: Female, Male All Sites · Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) All Sites · Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) All Sites · Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) All Sites · Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) All Sites · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) All Sites · Asian	2 Participants n=5 Participants
Race (NIH/OMB) All Sites · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) All Sites · Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) All Sites · White	29 Participants n=5 Participants
Race (NIH/OMB) All Sites · More than one race	0 Participants n=5 Participants
Race (NIH/OMB) All Sites · Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: one day

PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome.

Outcome measures

Measure	Interview Completion n=41 Participants The number of participants who completed the interview process.
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability Site 1 -- CHOP	20 Participants
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability Site 2 -- Cincinnati Children's Hospital	21 Participants

Adverse Events

Interview Completion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ignacio Tapia, MD

Children's Hospital of Philadelphia

Phone: (267) 426-5842

Email: tapia@chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place