Sleep Questionnaire Validation for Down Syndrome

Overseen By Derek Lam, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Tracheostomy, Tracheal stenosis, Cardiopulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This will be a prospective validation study of a sample of consecutive pediatric Down syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's. Questionnaires will be administered to approximately 5 new patients per month. Since this population has a higher prevalence of OSA than the general pediatric population, and OSA is a potentially modifiable determinant of quality of life, validated instruments are critical in assessing disease burden and response to treatment.

Who Is on the Research Team?

Derek Lam, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for children with Down syndrome aged 2-17 years who visit the Down syndrome clinic at OHSU/Doernbecher's. They must have had a recent sleep study or be scheduled for one, and their caregivers need to read English or Spanish. Kids with tracheostomy, airway narrowing, or severe heart/lung disease needing extra oxygen can't join.

Inclusion Criteria

My child with Down syndrome is between 2-17 years old and is seen at the Oregon Health and Science University.

My child has had a sleep study in the last 6 months and hasn't had surgery for sleep apnea since.

Exclusion Criteria

I have a narrowing in my windpipe.

I have a tracheostomy.

Parents or caregivers who are unable to read written English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Caregivers complete SRBD-PSQ, OSA-18, and PedsQL questionnaires; initial sleep study is conducted

1 month

1 visit (in-person)

Follow-up Assessment

Second sleep study conducted if needed, and follow-up questionnaires administered

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep study

Trial Overview The study aims to validate sleep questionnaires used in pediatric patients with Down syndrome by comparing questionnaire results with actual sleep studies. This helps understand the impact of obstructive sleep apnea on these kids' lives and check how well treatments are working.

How Is the Trial Designed?

Group I: Questionnaires and sleep studies Experimental Treatment 1 Intervention

Caregivers of patients meeting eligibility criteria will be invited to participate. If they agree to participate, baseline SRBD-PSQ, OSA-18, and PedsQL questionnaires along with written informed consent forms will be mailed to them along with their standard scheduling paperwork. Caregivers will be asked to review the consent form and complete the questionnaires and bring the paperwork to clinic on the day of their visit. Sleep study testing will also be ordered prior to their visit so that it can be scheduled within a month of the initial clinic visit and again three months later.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+