Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

N/AActive Not RecruitingNCT03478566

The Hospital for Sick Children39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Disorder; Breathing-Related Central Apnea Neuromuscular Diseases Obstructive Sleep Apnea

Interventions

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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 Outcomes

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.