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Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.
SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard NIMV protocol with sigh breaths | Experimental |
| |
| Standard NIMV protocol without sigh breaths | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIMV with sigh breaths | Device | Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( ≥ 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration | Evaluation will be performed before NIMV initiation and two months after |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test | Evaluation will be performed before NIMV initiation and two months after | |
| Changes in the arterial blood PO2 concentration assessed by arterial blood gas test | Evaluation will be performed before NIMV initiation and two months after |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| nilo riva, MD,PhD | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D016472 | Motor Neuron Disease |
| D012131 | Respiratory Insufficiency |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D012120 | Respiration Disorders |
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| Standard NIMV | Device | Will be treated by standard NIMV with no sigh |
|
| Changes in the arterial blood Ph assessed by arterial blood gas test | Evaluation will be performed before NIMV initiation and two months after |
| Changes in the forced vital capacity (FVC) assessed by spirometry test | Evaluation will be performed before NIMV initiation and two months after |
| Changes in self-perceived quality of life(QoL) assessed by 5-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5). Score between 0 and 100 pts (higher score denotes worse QoL) | Evaluation will be performed before NIMV initiation and two months after |
| Changes in sleep quality assessed by Pittsburg Sleep Quality Index (PSQI) questionnaire. Score between 0 to 21, where higher scores denote a worse sleep quality. | Evaluation will be performed before NIMV initiation and two months after |
| Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality. | Evaluation will be performed before NIMV initiation and two months after |
| Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea. | Evaluation will be performed before NIMV initiation and two months after |
| D012140 | Respiratory Tract Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |