Back to resultsTranscutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
Primary Purpose
Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcutaneous CO2 monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Disorder; Breathing-Related
Eligibility Criteria
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).
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcutaneous CO2 monitoring
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03478566
First Posted
March 20, 2018
Last Updated
April 10, 2023
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT03478566
Brief Title
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
Official Title
The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous CO2 monitoring
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcutaneous CO2 monitoring
Intervention Description
The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reshma Amin, MD
Organizational Affiliation
Staff Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
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