NCT05346263

Brief Summary

Non-Invasive Ventilation (NIV) is an established treatment to manage respiratory muscles dysfunction in neuromuscular disease, preventing the progression of respiratory failure to intubation and/or a tracheotomy. NIV is commonly needed at first during the night, but when the disease worsens, it is required during the day. It is provided via nasal or oronasal masks, causing discomfort and/or aesthetic issues that result in poor compliance. Intermittent Abdominal Pressure Ventilation (IAPV) is a valid, though unconventional, alternative to daytime NIV: it consists of a portable ventilator with an internal battery and a corset as interface. The IAPV corset is lightweight, comfortable and, thanks to velcro fasteners, easier and better fitting than a face mask. Cyclical inflation of a rubber bladder inside the corset moves the diaphragm upwards like a pneumobelt causing air to enter in the lungs via the upper airways as gravity draws the diaphragm back to its resting position. IAPV is indicated in neuromuscular disease and has already been tested in few preliminary studies and case reports. This study wants to verify the hypothesis of its application in population of neuromuscular patients.

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
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 19, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

April 13, 2022

Last Update Submit

December 15, 2022

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular Diseases;Intermittent Abdominal Pressure Ventilation;IAPV;

Outcome Measures

Primary Outcomes (1)

  • Blood Gas Analysis

    Changes of respiratory parameters in terms of normalization of oxyemia (Arterial Pressure of oxygen 80-100 mmHg) and normalization of capnia (Arterial Pressure of carbon dioxide 35-45 mmHg), assessed by blood gas analysis

    12 months

Secondary Outcomes (4)

  • Therapy adherence

    12 months

  • Patients satisfaction to IAPV

    12 months

  • Caregivers satisfaction to IAPV

    12 months

  • Amelioration of Quality of life

    12 months

Study Arms (2)

Intermittent Abdominal Pressure Ventilation

EXPERIMENTAL

Patients in experimental group will be adapted to Intermittent Abdominal Pressure Ventilation (IAPV). Abdominal ventilation replaces part of usual ventilation (non invasive ventilation with mouthpiece or nasal-pillow)

Device: Intermittent Abdominal Pressure Ventilation

Usual ventilation

ACTIVE COMPARATOR

Patients in control group continue with usual ventilation (NIV through mouthpiece or nasal-pillow)

Device: Usual ventilation

Interventions

Intermittent Abdominal Pressure VentilationDEVICE

Patients of experimental group will use IAPV in daytime ventilation. Intermittent abdominal pressure ventilation (IAPV) is a portable ventilator with an internal battery and PneumoBelt corset as an interface.

Also known as: IAPV
Intermittent Abdominal Pressure Ventilation
Usual ventilationDEVICE

NIV

Usual ventilation

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Neuromuscular Disease (Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Pompe Disease)
  • Non Invasive Ventilation \> 16 hours/day
  • Informed consent signed

You may not qualify if:

  • \- Diagnosis of kyphoscoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, 20146, Italy

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Paolo Banfi, MD

CONTACT

00390240308812pabanfi@dongnocchi.it

Valeria Volpi, PT

CONTACT

vvolpi@dongnocchi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 26, 2022

Study Start

March 1, 2022

Primary Completion

October 1, 2023

Study Completion

March 1, 2025

Last Updated

December 19, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)