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Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03478566
Recruitment Status : Active, not recruiting
First Posted : March 27, 2018
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Reshma Amin, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Sleep Disorder; Breathing-Related Central Apnea Neuromuscular Diseases Obstructive Sleep Apnea Device: Transcutaneous CO2 monitoring Not Applicable

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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

Resource links provided by the National Library of Medicine

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).

Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

Information from the National Library of Medicine

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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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03478566

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Reshma Amin, MD Staff Physician
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Responsible Party: Reshma Amin, Staff Physician, The Hospital for Sick Children 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

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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
Additional relevant MeSH terms:
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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
Nervous System Diseases
Neurologic Manifestations
Mental Disorders