Trials / Active Not Recruiting
Active Not RecruitingNCT03478566
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- The Hospital for Sick Children · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcutaneous CO2 monitoring | The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD). |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-12-31
- Completion
- 2023-09-01
- First posted
- 2018-03-27
- Last updated
- 2023-04-11
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03478566. Inclusion in this directory is not an endorsement.