Central Apnea, Neuromuscular Diseases, Obstructive Sleep Apnea, Sleep Disorder; Breathing-Related
Conditions
Brief summary
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.
Interventions
The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations * lives within the greater Toronto area.
Exclusion criteria
* known diagnosis of nocturnal hypoventilation * current ventilatory support * physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 9 months | b) Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG. |
Countries
Canada
Outcome results
None listed