Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

Obstructive Sleep Apnea Clinical Trial

Official title:

The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03478566
• Other study ID #: 1000059242
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: September 1, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Central Apnea
• Neuromuscular Diseases
• Obstructive Sleep Apnea
• Sleep Apnea, Central
• Sleep Apnea, Obstructive
• Sleep Disorder; Breathing-Related
• Sleep Wake Disorders

Intervention

Device:
• Transcutaneous CO2 monitoring
The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		9 months
Secondary	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.	9 months