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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
Sponsor:
Information provided by (Responsible Party):
Reshma Amin, The Hospital for Sick Children

Study Description
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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

Study Design
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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

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Arms and Interventions
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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).


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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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


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Reshma Amin, MD Staff Physician
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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

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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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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