Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

The Hospital for Sick Children

Status: Active, not recruiting

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

Treatments: Device: Transcutaneous CO2 monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03478566

1000059242

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Transcutaneous CO2 monitoring

Experimental group

Treatment:

Device: Transcutaneous CO2 monitoring