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

Sponsor

Ospedale San Raffaele (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04240925

Collaborator

(none)

Enrollment

Location

Arms

55.2

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Motor Neuron Disease Respiratory Failure Amyotrophic Lateral Sclerosis	Device: NIMV with sigh breaths Device: Standard NIMV	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale San Raffaele	Milano		Italy	20132

Sponsors and Collaborators

Ospedale San Raffaele

Investigators

Principal Investigator: nilo riva, MD,PhD, Ospedale San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nilo Riva, Principal Investigator, Ospedale San Raffaele

ClinicalTrials.gov Identifier:

NCT04240925

Other Study ID Numbers:

SIGH_01

First Posted:

Jan 27, 2020

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Mar 16, 2022