NCT04240925

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

January 16, 2020

Last Update Submit

March 15, 2022

Conditions

Motor Neuron DiseaseRespiratory FailureAmyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration

    Evaluation will be performed before NIMV initiation and two months after

Secondary Outcomes (8)

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Standard NIMV protocol with sigh breaths

EXPERIMENTAL
Device: NIMV with sigh breaths

Standard NIMV protocol without sigh breaths

ACTIVE COMPARATOR
Device: Standard NIMV

Interventions

NIMV with sigh breathsDEVICE

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

Standard NIMV protocol with sigh breaths
Standard NIMVDEVICE

Will be treated by standard NIMV with no sigh

Standard NIMV protocol without sigh breaths

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to give informed consent
  • MND diagnosis according to El-Escorial criteria
  • Non-invasive ventilation indications in accordance with the international guidelines

You may not qualify if:

  • Inability to adhere to study visit schedule or lack of reliable caretaker
  • Presence of dementia
  • History of arrhythmia, heart failure or pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Motor Neuron DiseaseRespiratory InsufficiencyAmyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesRespiration DisordersRespiratory Tract DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • nilo riva, MD,PhD

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 27, 2020

Study Start

May 25, 2018

Primary Completion

April 30, 2022

Study Completion

December 31, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)