Down Syndrome, Obstructive Sleep Apnea
Conditions
Keywords
Down Syndrome, Obstructive Sleep Apnea
Brief summary
To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndrome (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.
Interventions
BEHAVIORALOpen-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.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interview Completion The number of participants who completed the interview process. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen failure | 1 |
Baseline characteristics
| Characteristic | Interview Completion |
|---|---|
| Age, Customized Age at screening | 12.6 years STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) All Sites Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) All Sites Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) All Sites Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) All Sites American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) All Sites Asian | 2 Participants |
| Race (NIH/OMB) All Sites Black or African American | 10 Participants |
| Race (NIH/OMB) All Sites More than one race | 0 Participants |
| Race (NIH/OMB) All Sites Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) All Sites Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) All Sites White | 29 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male All Sites Female | 28 Participants |
| Sex: Female, Male All Sites Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability
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.
Time frame: one day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Completion | Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability | Site 1 -- CHOP | 20 Participants |
| Interview Completion | Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability | Site 2 -- Cincinnati Children's Hospital | 21 Participants |