Validation of Sleep Questionnaires in the Down Syndrome Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03771469|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Down Syndrome||Diagnostic Test: Sleep study||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Validation of Sleep Questionnaires in the Down Syndrome Population|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||April 2020|
Experimental: Questionnaires and sleep studies
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.
Diagnostic Test: Sleep study
Other Name: polysomnography
- 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).
- Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ) [ Time Frame: SRBD score tallied at initial clinic visit. ]The SRBD-PSQ is a subjective instrument with 22-items that was designed to screen for sleep-related disordered breathing in the general pediatric population. Each question is answered with a yes (1 point), no (0 points), or don't know (0 points). The total number of points is added up, and that sum is divided by the number of questions answered to produce a ratio. When assessing the ratio, a figure greater than 0.3 is considered a positive screening for OSA. There are no subscales on this questionnaire.
- Sleep-Related Quality of Life (OSA-18 total score) [ Time Frame: OSA-18 total collected at initial clinic visit. ]The OSA-18 is a subjective measure of disease-specific quality of life survey for sleep disordered breathing. It contains 18 questions. These questions are scored on a 7 point Likert scale, with "1" being the worst outcome and "7" being the best outcome. These numeric scores are totaled to produce one overall sum, with a range from 7 to 126.
- Generic Quality of Life [ Time Frame: PedsQL summary scores collected at initial clinic visit. ]The Pediatric Quality of Life Inventory (PedsQL) is a validated generic quality of life measure encompassing 4 multidimensional scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) with three Summary Scores (Total Score, Physical Health Summary Score, Psychosocial Health Summary Score). The number of questions varies by age group but falls within 20-25 questions. The questions use 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0.). Dimensions are scored by transforming into mean score = Sum of the items over the number of items answered. For each of the 4 scales, higher scores indicate better HRQOL (better outcome).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771469
|Contact: Eleni O'Neillemail@example.com|
|Contact: Derek Lam, MDfirstname.lastname@example.org|
|United States, Oregon|
|Doernbecher Children's Hospital||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Eleni I O'Neill 503-494-3569 email@example.com|
|Contact: Derek Lam, MD, MPH 503-494-9419 firstname.lastname@example.org|
|Principal Investigator: Derek Lam, MD, MPH|
|Principal Investigator:||Derek Lam, MD||Oregon Health and Science University|