Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478566
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 23, 2019
Sponsor:
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 1, 2020

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

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 ClinicalTrials.gov identifier (NCT number): NCT03478566


Contacts
Layout table for location contacts
Contact: Reshma Amin, MD 416-813-6346 reshma.amin@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Reshma Amin, MD    416-813-6346 ext 206346    reshma.amin@sickkids.ca   
Contact: Shahjereen Shahidullah    416-813-7654 ext 328361    shahjereen.shahidullah@sickkids.ca   
Principal Investigator: Reshma Amin, MD         
Sub-Investigator: Suhail Al-Saleh, MD         
Sub-Investigator: Snow Nadia, RRT         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Reshma Amin, MD Staff Physician

Layout table for additonal information
Responsible Party: Reshma Amin, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03478566     History of Changes
Other Study ID Numbers: 1000059242
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Neuromuscular Diseases
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders