Portable Sleep Monitors in Children With Autism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorLena Xiao
About this trial
The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to:
1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG); 2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA); 3. Evaluate patient and family preferences for sleep testing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children between 6 to 18 years of age, AND;
Children diagnosed with autism spectrum disorder, AND;
Children who will be undergoing a polysomnogram (PSG) for the first time, AND;
Caregiver willing to complete questionnaires about child's sleep and behavior
Disqualifiers
Children who are currently using respiratory therapy
Children who have previously completed a PSG
Caregiver unwilling to complete questionnaires about child's sleep and behavior
Trial population
Children who are undergoing a clinical PSG at British Columbia's Children's Hospital in Vancouver, Canada.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Portable sleep monitor (Nox T3s)
DeviceParticipants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Children with ASD testing a portable sleep monitor1 intervention
Trial outcomes
Primary outcomes
1
Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG)
The OAHI measured from the portable sleep monitor will be compared to the OAHI measured from the PSG, the gold standard test for sleep-disordered breathing, to determine the ability of the portable sleep monitor to diagnose obstructive sleep apnea.
Time frame
BaselineSecondary outcomes
1
Patient and Family Preferences
Optional semi-structured qualitative interviews with caregivers and the patient, if they choose to and are capable of participating in the interviews. The interviews will be conducted virtually by a study team member to explore patient and family preferences and experiences with diagnostic sleep testing.
Time frame
0-3 months after the baseline PSG2
Insomnia Questionnaire
The caregiver-reported Pediatric Insomnia Severity Index will be used to measure the severity of pediatric insomnia symptoms. Scores range from 0 to 30, with higher scores indicating greater insomnia severity.
Time frame
+/- 1 week from baseline PSG sleep test3
Chronotype Questionnaire
The caregiver-reported Children's Chronotype Questionnaire will measure the chronotype of the participant. The caregiver is given a short description of different chronotypes and selects the chronotype that best reflects their child's preference from a 5-point scale, ranging from "Definitely a Morning Type" = 1 to "Definitely an Evening Type" = 5.
Time frame
+/- 1 week from baseline PSG sleep test4
Chronotype Questionnaire
The Morningness/Eveningness Scale from the caregiver-reported Children's Chronotype Questionnaire will measure the participant's differences in activeness and alertness in the mornings and evenings. Scores range from 10-48, with scores indicating a morning type (≤ 23), intermediate type (24-32), and evening type (≥33).
Time frame
+/- 1 week from baseline PSG sleep testSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lena Xiao
Lead sponsor
University of British Columbia
Sponsor institution
Source ClinicalTrials.gov