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Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange (ANEX)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telerehabilitation solution (m-Rehab)
Usual management including NIV.
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis (ALS), Non invasive ventilation, Telemonitoring, Telemedicine, Multidisciplinary approach

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients between 30 and 85 years old Diagnosis of ALS Indication and acceptance of non-invasive ventilation Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home Patient able to read and understand the procedure, and able to express consent for the study protocol Exclusion Criteria: Treatment with non-invasive ventilation in the previous three months Refusal/inability to use a smart phone or digital device Patient currently participating or having participated in the month preceding inclusion in another clinical interventional research that could impact the study, this impact is left to the discretion of the investigator. Subject under guardianship or curators Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme. Subject deprived of liberty by judicial or administrative decision Pregnant, parturient, breastfeeding women Refusal to give consent

Sites / Locations

  • Uh MontpellierRecruiting
  • Clinique du MillénaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control Comparator

Arm Description

A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

A group of 29 patients with ALS will be formed : control group following usual management including NIV. Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

Outcomes

Primary Outcome Measures

Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at Baseline (D0) and 6 months between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality

Secondary Outcome Measures

Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at 3 month and 6 month between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).
Difference in variation of the functional capabilities assessed by the ALSFRS score at Baseline (D0) and 3 month between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Evolution of dyspnea between the 2 groups between baseline and 3 months
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Evolution of dyspnea between the 2 groups between baseline and 6 months
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Evolution of Quality of life between the 2 groups between baseline and 3 months
Quality of life assessed by the EuroQol-5 Dimensions (EQ5D) scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Evolution of Quality of life between the 2 groups between baseline and 6 months
Quality of life assessed by the EQ5D scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months
Anxiety and depression assessed by the Hospital Anxiety and Depression (HAD) scale. The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months
Anxiety and depression assessed by the HAD scale. The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Evolution of Patient satisfaction between the 2 groups between baseline and 3 months
Patient satisfaction assessed by the CSQ-8 (Consumer satisfaction questionnaire) Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Patient satisfaction between the 2 groups between baseline and 6 months
Patient satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
Weight measurements
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
BMI
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
weight measurements
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
BMI
Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry
The effectiveness of NIV assessed by nocturnal oximetry
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry
The effectiveness of NIV assessed by nocturnal oximetry
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography
The effectiveness of NIV assessed by nocturnal capnography
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography
The effectiveness of NIV assessed by nocturnal capnography
Evaluation of the NIV parameters between the 2 groups at 3 months
NIV parameters obtained using data from the machine report
Evaluation of the NIV parameters between the 2 groups at 6 months
NIV parameters obtained using data from the machine report
Evaluation of survival between the 2 groups at 3 months
Evaluation of survival between the 2 groups at 3 months
Evaluation of survival between the 2 groups at 6 months
Evaluation of survival between the 2 groups at 6 months
Evaluation of time to first hospitalization between the 2 groups at 3 months
recovery of hospitalization data
Evaluation of time to first hospitalization between the 2 groups at 6 months
recovery of hospitalization data
Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Medico-economic evaluation: incremental cost-utility ratio
Utility will be derived from the EQ5D
Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction

Full Information

First Posted
April 19, 2023
Last Updated
July 7, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05837507
Brief Title
Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange
Acronym
ANEX
Official Title
Contribution of a Multimodal Digital Platform in the Management and Follow-up of Patients With Amyotrophic Lateral Sclerosis Treated With Non-invasive Ventilation: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a median life expectancy of 3 to 5 years. Respiratory failure due to alveolar hypoventilation is the main cause of mortality and respiratory impairment leads to a significant deterioration in quality of life. Non-invasive ventilation (NIV) improves patient quality of life, improves gas exchange and improves patient survival. NIV should be initiated early, based on symptomatology and lung function, and monitored closely to adjust device parameters. NIV is a complex intervention that must be individualized for each patient. In addition, multidisciplinary management involving different healthcare professionals, keeping the patient and caregivers at the center of the network, also allows for an improvement in the quality of life and survival of these patients. However, patients with ALS have difficulty moving around and access to care becomes more complicated as the disease progresses. This phenomenon was increased during the COVID- 19 pandemic with a more rapid functional decline. The development of new technologies should make it possible to rethink patient management, in particular through remote monitoring of NIV devices, teleconsultation, administration of questionnaires and better interprofessional organization. Several studies have confirmed the feasibility and acceptance of telemedicine solutions in this population. In this project, The research team hypothesize that the use of a multimodal digital platform will slow the progression of disability in ALS patients and improve their quality of life, in particular by improving the quality of NIV and optimizing the coordination of a multidisciplinary team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis (ALS), Non invasive ventilation, Telemonitoring, Telemedicine, Multidisciplinary approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, two-armed, interventional controlled study versus multicenter, open-label study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.
Arm Title
Control Comparator
Arm Type
Active Comparator
Arm Description
A group of 29 patients with ALS will be formed : control group following usual management including NIV. Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation solution (m-Rehab)
Intervention Description
Patients in the experimental group will have access to a multimodal digital platform (m-Rehab®). The solution includes a website and an application available on smart phones for the patient and caregivers. Patients and caregivers will have access to educational content about the condition and its treatments, NIV compliance data, digital group educational workshops, secure messaging and video conferencing. All the professionals forming the patient's circle of care will be able to have access to the solution, after the patient's authorization. The circle of care, in a non-exhaustive way, includes specialist doctors, the general practitioner, the staff of the reference center of the Montpellier University Hospital, the physiotherapist, the speech therapist, the dietician and the psychologist.
Intervention Type
Other
Intervention Name(s)
Usual management including NIV.
Intervention Description
Usual management including NIV.
Primary Outcome Measure Information:
Title
Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
Description
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at Baseline (D0) and 6 months between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Time Frame
Between baseline and 6 months
Secondary Outcome Measure Information:
Title
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).
Description
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at 3 month and 6 month between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Time Frame
Between 3 months and 6 months
Title
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).
Description
Difference in variation of the functional capabilities assessed by the ALSFRS score at Baseline (D0) and 3 month between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Time Frame
Between Baseline and 3 months
Title
Evolution of dyspnea between the 2 groups between baseline and 3 months
Description
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Time Frame
Between Baseline and 3 months
Title
Evolution of dyspnea between the 2 groups between baseline and 6 months
Description
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Time Frame
Between Baseline and 6 months
Title
Evolution of Quality of life between the 2 groups between baseline and 3 months
Description
Quality of life assessed by the EuroQol-5 Dimensions (EQ5D) scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
Between Baseline and 3 months
Title
Evolution of Quality of life between the 2 groups between baseline and 6 months
Description
Quality of life assessed by the EQ5D scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
Between Baseline and 6 months
Title
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months
Description
Anxiety and depression assessed by the Hospital Anxiety and Depression (HAD) scale. The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Time Frame
Between Baseline and 3 months
Title
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months
Description
Anxiety and depression assessed by the HAD scale. The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Time Frame
Between Baseline and 6 months
Title
Evolution of Patient satisfaction between the 2 groups between baseline and 3 months
Description
Patient satisfaction assessed by the CSQ-8 (Consumer satisfaction questionnaire) Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Time Frame
Between Baseline and 3 months
Title
Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months
Description
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Time Frame
Between Baseline and 3 months
Title
Evolution of Patient satisfaction between the 2 groups between baseline and 6 months
Description
Patient satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Time Frame
Between Baseline and 6 months
Title
Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months
Description
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Time Frame
Between Baseline and 6 months
Title
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
Description
Weight measurements
Time Frame
Between Baseline and 3 months
Title
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
Description
BMI
Time Frame
Between Baseline and 3 months
Title
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
Description
weight measurements
Time Frame
Between Baseline and 6 months
Title
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
Description
BMI
Time Frame
Between Baseline and 6 months
Title
Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months
Description
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Time Frame
At 3 months
Title
Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months
Description
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Time Frame
At 6 months
Title
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry
Description
The effectiveness of NIV assessed by nocturnal oximetry
Time Frame
At 3 months
Title
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry
Description
The effectiveness of NIV assessed by nocturnal oximetry
Time Frame
At 6 months
Title
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography
Description
The effectiveness of NIV assessed by nocturnal capnography
Time Frame
At 3 months
Title
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography
Description
The effectiveness of NIV assessed by nocturnal capnography
Time Frame
At 6 months
Title
Evaluation of the NIV parameters between the 2 groups at 3 months
Description
NIV parameters obtained using data from the machine report
Time Frame
At 3 months
Title
Evaluation of the NIV parameters between the 2 groups at 6 months
Description
NIV parameters obtained using data from the machine report
Time Frame
At 6 months
Title
Evaluation of survival between the 2 groups at 3 months
Description
Evaluation of survival between the 2 groups at 3 months
Time Frame
At 3 months
Title
Evaluation of survival between the 2 groups at 6 months
Description
Evaluation of survival between the 2 groups at 6 months
Time Frame
At 6 months
Title
Evaluation of time to first hospitalization between the 2 groups at 3 months
Description
recovery of hospitalization data
Time Frame
At 3 months
Title
Evaluation of time to first hospitalization between the 2 groups at 6 months
Description
recovery of hospitalization data
Time Frame
At 6 months
Title
Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution
Description
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 3 months
Title
Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution
Description
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 6 months
Title
Medico-economic evaluation: incremental cost-utility ratio
Description
Utility will be derived from the EQ5D
Time Frame
6 months
Title
Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution
Description
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 3 months
Title
Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution
Description
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 6 months
Title
Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution
Description
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 3 months
Title
Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution
Description
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 30 and 85 years old Diagnosis of ALS Indication and acceptance of non-invasive ventilation Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home Patient able to read and understand the procedure, and able to express consent for the study protocol Exclusion Criteria: Treatment with non-invasive ventilation in the previous three months Refusal/inability to use a smart phone or digital device Patient currently participating or having participated in the month preceding inclusion in another clinical interventional research that could impact the study, this impact is left to the discretion of the investigator. Subject under guardianship or curators Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme. Subject deprived of liberty by judicial or administrative decision Pregnant, parturient, breastfeeding women Refusal to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francois BUGHIN, MD
Phone
04.67.33.82.84
Ext
33
Email
f-bughin@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois BUGHIN, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Uh Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCOIS BUGHIN, MD
Phone
04.67.33.82.84
Ext
33
Email
f-bughin@chu-montpellier.fr
Facility Name
Clinique du Millénaire
City
Montpellier
ZIP/Postal Code
34960
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois BUGHIN, MD
Email
f.bughin@millenaire.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

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