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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
Children with Down syndrome aged 2-17 years who are seen through the Down syndrome clinic at Oregon Health and Science University
Children who either have a recently completed sleep study (within the past 6 months and no surgical treatment for OSA since then) or who will be having a sleep study
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

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child with Down syndrome is between 2-17 years old and is seen at the Oregon Health and Science University.
Select...
My child has had a sleep study in the last 6 months and hasn't had surgery for sleep apnea since.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea-hypopnea index (AHI) from polysomnography
Secondary outcome measures
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)

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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
966 Previous Clinical Trials
6,845,670 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.

Media Library

Sleep study Clinical Trial Eligibility Overview. Trial Name: NCT03771469 — N/A
Down Syndrome Research Study Groups: Questionnaires and sleep studies
Down Syndrome Clinical Trial 2023: Sleep study Highlights & Side Effects. Trial Name: NCT03771469 — N/A
Sleep study 2023 Treatment Timeline for Medical Study. Trial Name: NCT03771469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Mar 2025