Back to resultsTolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
Primary Purpose
Motor Neuron Disease, Respiratory Failure, Amyotrophic Lateral Sclerosis
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NIMV with sigh breaths
Standard NIMV
Sponsored by
About this trial
This is an interventional supportive care trial for Motor Neuron Disease
Eligibility Criteria
Inclusion Criteria:
- Willing and able to give informed consent
- MND diagnosis according to El-Escorial criteria
- Non-invasive ventilation indications in accordance with the international guidelines
Exclusion Criteria:
- Inability to adhere to study visit schedule or lack of reliable caretaker
- Presence of dementia
- History of arrhythmia, heart failure or pneumothorax
Sites / Locations
- Ospedale San Raffaele
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard NIMV protocol with sigh breaths
Standard NIMV protocol without sigh breaths
Arm Description
Outcomes
Primary Outcome Measures
Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
Secondary Outcome Measures
Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test
Changes in the arterial blood PO2 concentration assessed by arterial blood gas test
Changes in the arterial blood Ph assessed by arterial blood gas test
Changes in the forced vital capacity (FVC) assessed by spirometry test
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)
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.
Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality.
Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04240925
Brief Title
Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
Official Title
Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Neuron Disease, Respiratory Failure, Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard NIMV protocol with sigh breaths
Arm Type
Experimental
Arm Title
Standard NIMV protocol without sigh breaths
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NIMV with sigh breaths
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard NIMV
Intervention Description
Will be treated by standard NIMV with no sigh
Primary Outcome Measure Information:
Title
Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Secondary Outcome Measure Information:
Title
Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
Changes in the arterial blood PO2 concentration assessed by arterial blood gas test
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
Changes in the arterial blood Ph assessed by arterial blood gas test
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
Changes in the forced vital capacity (FVC) assessed by spirometry test
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
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)
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
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.
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality.
Time Frame
Evaluation will be performed before NIMV initiation and two months after
Title
Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea.
Time Frame
Evaluation will be performed before NIMV initiation and two months after
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to give informed consent
MND diagnosis according to El-Escorial criteria
Non-invasive ventilation indications in accordance with the international guidelines
Exclusion Criteria:
Inability to adhere to study visit schedule or lack of reliable caretaker
Presence of dementia
History of arrhythmia, heart failure or pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nilo riva, MD,PhD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
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