Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

Not Applicable

Active, not recruiting

• Conditions: Central Apnea; Obstructive Sleep Apnea; Sleep Disorder; Breathing-Related; Neuromuscular Diseases
• Interventions: Device: Transcutaneous CO2 monitoring

• Registration Number: NCT03478566
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Study Start: 2018-10-01
• Primary Completion: 2021-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcutaneous CO2 monitoring	Transcutaneous CO2 monitoring	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.	9 months	b) Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada