Validation of Sleep Questionnaires in the Down Syndrome Population

NCT03771469 | Active Not Recruiting

• 1 other identifier: STUDY00018522
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Down Syndrome

Keywords

OSA; obstructive sleep apnea; Down syndrome; sleep questionnaires; sleep study

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI) from polysomnography

  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).

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

Secondary Outcomes (3)

• 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.

Study Arms (1)

Questionnaires and sleep studies

EXPERIMENTAL

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

Interventions

Sleep study OTHER

Sleep study

Also known as: polysomnography

Questionnaires and sleep studies

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Down Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Derek Lam, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: December 11, 2018
• Study Start: June 25, 2018
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)