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

Not Applicable

• Conditions: Respiratory Failure; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Interventions: Device: NIMV with sigh breaths; Device: Standard NIMV

• Registration Number: NCT04240925
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-25
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16
• Primary Completion: 2022-04-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard NIMV protocol with sigh breaths	NIMV with sigh breaths	-
Standard NIMV protocol without sigh breaths	Standard NIMV	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 the arterial blood PO2 concentration assessed by arterial blood gas test	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
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 forced vital capacity (FVC) assessed by spirometry test	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

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milano, Italy