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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous CO2 monitoring | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous CO2 monitoring | Device | The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reshma Amin, MD | Staff Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36435158 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2023 | Dec 13, 2023 | 7 | ||
| Oct 25, 2024 |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D020182 | Sleep Apnea, Central |
| D009468 | Neuromuscular Diseases |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nov 18, 2024 |
| 8 |
| Jun 6, 2025 | Jun 25, 2025 | 9 |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |