Active — Not RecruitingNot Applicable

Validation of Sleep Questionnaires in the Down Syndrome Population

United States81 participantsStarted 2018-06-25

Plain-language summary

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 can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Children with Down syndrome aged 2-17 years who are seen through the Down syndrome clinic at Oregon Health and Science University 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. Exclusion Criteria: * Presence of tracheostomy * Presence of subglottic or tracheal stenosis * Severe cardiopulmonary disease requiring supplemental oxygen * Parents or caregivers who are unable to read written English or Spanish

What they're measuring

Apnea-hypopnea index (AHI) from polysomnography

Timeframe: AHI collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)

Trial details

NCT IDNCT03771469

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials