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Sleep Questionnaire Validation for Down Syndrome

N/A

Waitlist Available

Led By Derek Lam, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ahi collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a questionnaire can accurately identify sleep apnea in children with Down syndrome.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves answering questionnaires related to sleep patterns and quality, there are no direct physical side effects from participating in this research.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ahi collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ahi collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)

This trial's timeline: 3 weeks for screening, Varies for treatment, and ahi collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apnea-hypopnea index (AHI) from polysomnography

Secondary study objectives

Generic Quality of Life

Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ)

Sleep-Related Quality of Life (OSA-18 total score)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Questionnaires and sleep studiesExperimental Treatment1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

1,006 Previous Clinical Trials

7,413,891 Total Patients Enrolled

4 Trials studying Down Syndrome

359 Patients Enrolled for Down Syndrome

Derek Lam, MD1.01 ReviewsPrincipal Investigator - Oregon Health and Science University

Oregon Health and Science University

1 Previous Clinical Trials

240 Total Patients Enrolled

1Patient Review

We were incredibly disappointed by Dr. Lam. He was cocky and failed to deliver on the care he promised our RARE, medically fragile child. We're grateful to the PICU team for stepping in when they did. If you choose to use Dr. Lam, don't expect him to be around when you need him most. You'll be left in the hands of residents. And his pain management skills were terrible.