Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

NCT ID: NCT03478566

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transcutaneous CO2 monitoring

Group Type EXPERIMENTAL

Transcutaneous CO2 monitoring

Intervention Type DEVICE

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

Interventions

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Transcutaneous CO2 monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Reshma Amin

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reshma Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Physician

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 36435158 (View on PubMed)

Other Identifiers

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1000059242

Identifier Type: -

Identifier Source: org_study_id

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