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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04240925
• Other study ID #: SIGH_01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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
• Standard NIMV
Will be treated by standard NIMV with no sigh

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test		Evaluation will be performed before NIMV initiation and two months after
Secondary	Changes in the arterial blood PO2 concentration assessed by arterial blood gas test		Evaluation will be performed before NIMV initiation and two months after
Secondary	Changes in the arterial blood Ph assessed by arterial blood gas test		Evaluation will be performed before NIMV initiation and two months after
Secondary	Changes in the forced vital capacity (FVC) assessed by spirometry test		Evaluation will be performed before NIMV initiation and two months after
Secondary	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
Secondary	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
Secondary	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
Secondary	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