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
Among 37 studies in Sleep Wake Disorders with a site in Canada — 15 open to participants now, 17 under way, 3 of them phase 3. Sleep Wake Disorders · Canada.
Among the 37 studies in Sleep Wake Disorders with a site in Canada, this one is the 18th largest by enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2018, is one of 12 with no phase, reaches primary completion later than 0 of the 16 other live ones, and was the 17th registered.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's enrollment of 39 is below the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →15 of the 37 studies in Sleep Wake Disorders with a site in Canada are open now.
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 109 Sleep Wake Disorders studies recruiting now, 36 (33%) set no upper age limit and 53 (49%) stop at 75 or younger; 22 take children under 18; 24 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 3 · Phase 3 6 · Phase 4 5
First in 2001; this study’s year is marked. 4 started in 2018.
Median enrollment 74 across the 28 interventional studies, 174 across the 9 observational. Of the 17 that completed or were terminated, 3 (18%) have results posted.
7 of 37 have an industry lead sponsor. The 10 most frequent:
The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
The Hospital for Sick Children has 3 studies filed under Sleep Wake Disorders — fewer than ten, so there is no comparison to draw.
6 of the studies in Sleep Wake Disorders with a site in Canada that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07540897Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) | 2027-06 |
| NCT07301567University of British ColumbiaPilot Study of Negative Pressure Neck Therapy (NPNT) | 2026-12 |
| NCT07367022Lena XiaoPortable Sleep Monitors in Children With Autism Spectrum Disorder | 2026-12-31 |
Among the 37 studies in Sleep Wake Disorders with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Dec 2021, 38 months.
Of 208 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's 38 months is above that.
Counting every sponsor, half of 243 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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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