Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
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ClinicalTrials.gov Identifier: NCT03478566 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2018
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Disorder; Breathing-Related Central Apnea Neuromuscular Diseases Obstructive Sleep Apnea | Device: Transcutaneous CO2 monitoring | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease |
Actual Study Start Date : | October 1, 2018 |
Actual Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Transcutaneous CO2 monitoring |
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. [ Time Frame: 9 months ]b) Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG.

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478566
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Reshma Amin, MD | Staff Physician |
Responsible Party: | Reshma Amin, Staff Physician, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT03478566 |
Other Study ID Numbers: |
1000059242 |
First Posted: | March 27, 2018 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Apnea Sleep Apnea, Obstructive Sleep Apnea, Central Sleep Wake Disorders Neuromuscular Diseases Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Neurologic Manifestations Mental Disorders |