Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

NCT03478566 | Active Not Recruiting FDA Device

• 1 other identifier: 1000059242
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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).

  9 months

Secondary Outcomes (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.

  9 months

Study Arms (1)

Transcutaneous CO2 monitoring

EXPERIMENTAL

Device: Transcutaneous CO2 monitoring

Interventions

Transcutaneous CO2 monitoring DEVICE

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

Transcutaneous CO2 monitoring

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
• lives within the greater Toronto area.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Shi J, Chiang J, Ambreen M, Snow N, Mocanu C, McAdam L, Goldstein RS, Rose L, Amin R. Ambulatory transcutaneous carbon dioxide monitoring for children with neuromuscular disease. Sleep Med. 2023 Jan;101:221-227. doi: 10.1016/j.sleep.2022.10.028. Epub 2022 Nov 2.

  PMID: 36435158 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea, Central; Neuromuscular Diseases; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Reshma Amin, MD

  Staff Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: September 1, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

CA (1)