An interventional study of Transcutaneous CO2 monitoring in Sleep Disorder; Breathing-Related, Central Apnea and Neuromuscular Diseases, sponsored by The Hospital for Sick Children. Active, not recruiting at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.
Exclusion Criteria:
Device: Transcutaneous CO2 monitoring
The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
Time frame: 9 months
a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation.
b) Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG.
Time frame: 9 months
Plan to share: Undecided
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This study is active, not recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children