Validation of Sleep Questionnaires in the Down Syndrome Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Apnea-hypopnea index (AHI) from polysomnography
Study Overview
Brief 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.
Detailed Description
Specific Aims:
- Demonstrate the criterion validity of the Sleep-Related Breathing Disorder subscale of the PSQ as a screening tool for the diagnosis of OSA in children with Down Syndrome, using polysomnography as the gold standard.
Hypothesis: Compared to the published threshold for a positive screen in the general pediatric population (≥ 7 of 22 positive responses), the threshold for a positive screen that corresponds to an optimal sensitivity and specificity in the Down syndrome population will be significantly different. 2. Demonstrate the construct validity of the OSA-18 as a scale to assess sleep-related quality of life in children with Down Syndrome by comparing OSA-18 scores to an objective measure of disease burden (polysomnography) and a generic quality of life instrument (the Pediatric Quality of Life inventory, PedsQL).
Hypothesis: OSA-18 scores will be significantly associated with the Apnea-Hypopnea Index assessed by polysomnography and the PedsQL Total Score, Physical Health, and Psychosocial Health summary scores.
Background:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Apnea-hypopnea index (AHI) from polysomnography
Time Frame: AHI collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)
Overnight attended polysomnography is the gold standard for diagnosis of OSA. Assessment of sleep staging is done through electroencephalogram, electro-oculogram, and submental electromyogram. The primary output parameter that is commonly used to diagnose and characterize the severity of OSA is the apnea-hypopnea index (AHI).
Secondary Outcomes
- Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ)(SRBD score tallied at initial clinic visit.)
- Sleep-Related Quality of Life (OSA-18 total score)(OSA-18 total collected at initial clinic visit.)
- Generic Quality of Life(PedsQL summary scores collected at initial clinic visit.)
Investigators
Derek Lam, MD, MPH
Assistant Professor
Oregon Health and Science University