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Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240925
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nilo Riva, Ospedale San Raffaele

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.


Condition or disease Intervention/treatment Phase
Motor Neuron Disease Respiratory Failure Amyotrophic Lateral Sclerosis Device: NIMV with sigh breaths Device: Standard NIMV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Standard NIMV protocol with sigh breaths Device: NIMV with sigh breaths
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

Active Comparator: Standard NIMV protocol without sigh breaths Device: Standard NIMV
Will be treated by standard NIMV with no sigh




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Changes in the forced vital capacity (FVC) assessed by spirometry test [ Time Frame: Evaluation will be performed before NIMV initiation and two months after ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240925


Contacts
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Contact: Nilo Riva, MD,PhD 0226435293 riva.nilo@hsr.it

Locations
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Italy
Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Nilo Riva, MD,PhD    02264352930    riva.nilo@hsr.it   
Sub-Investigator: Yuri Matteo Falzone, MD         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
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Principal Investigator: nilo riva, MD,PhD Ospedale San Raffaele
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Responsible Party: Nilo Riva, Principal Investigator, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT04240925    
Other Study ID Numbers: SIGH_01
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Respiration Disorders
Respiratory Tract Diseases
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases