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Validation of Sleep Questionnaires in the Down Syndrome Population

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ClinicalTrials.gov Identifier: NCT03771469
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 23, 2023
Information provided by (Responsible Party):
Derek Lam, MD, MPH, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Down Syndrome Other: Sleep study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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)
Primary Purpose: Screening
Official Title: Validation of Sleep Questionnaires in the Down Syndrome Population
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
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.
Other: Sleep study
Sleep study
Other Name: polysomnography

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

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

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Contact: Eleni O'Neill 503-494-3569 oneilele@ohsu.edu
Contact: Derek Lam, MD 503-494-9419 lamde@ohsu.edu

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United States, Oregon
Doernbecher Children's Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Eleni I O'Neill    503-494-3569    sabine26@gmail.com   
Contact: Derek Lam, MD, MPH    503-494-9419    lamde@ohsu.edu   
Principal Investigator: Derek Lam, MD, MPH         
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Derek Lam, MD Oregon Health and Science University

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Responsible Party: Derek Lam, MD, MPH, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03771469    
Other Study ID Numbers: STUDY00018522
GOTOL0341A ( Other Grant/Funding Number: Amer Acad Otolaryngology Head/Neck Surgery Fdtn )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the PI and members of the study team will have direct access to identifiable private information. Subjects will be assigned a unique randomly generated study identification number and extracted datasets will be coded for use in subsequent analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Derek Lam, MD, MPH, Oregon Health and Science University:
obstructive sleep apnea
Down syndrome
sleep questionnaires
sleep study
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Down Syndrome
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn