Amyotrophic Lateral SclerosisANEXNCT05837507
Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange
A study testing Telerehabilitation solution (m-Rehab) and Usual management including NIV. in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Telerehabilitation solution (m-Rehab) and Usual management including NIV.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jul 2023to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Uh Montpellier
Montpellier, Montpellier, 34295
Clinique du Millénaire
Montpellier, 34960
About this study
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
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Telerehabilitation solution (m-Rehab), Usual management including NIV.
- Keywords
- Amyotrophic lateral sclerosis (ALS), Non invasive ventilation, Telemonitoring, Telemedicine, Multidisciplinary approach
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation solution (m-Rehab)Other
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.
Usual management including NIV.Other
Usual management including NIV.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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. Receives: Other: Telerehabilitation solution (m-Rehab); Other: Usual management including NIV. |
| Control Comparator | Active comparator | 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. Receives: Other: Usual management including NIV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between baseline and 6 months
Secondary outcomes (35)
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
Measured: Between 3 months and 6 months
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
Measured: Between Baseline and 3 months
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).
Measured: Between Baseline and 3 months
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).
Measured: Between Baseline and 6 months
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.
Measured: Between Baseline and 3 months
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.
Measured: Between Baseline and 6 months
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).
Measured: Between Baseline and 3 months
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).
Measured: Between Baseline and 6 months
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.
Measured: Between Baseline and 3 months
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.
Measured: Between Baseline and 3 months
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.
Measured: Between Baseline and 6 months
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.
Measured: Between Baseline and 6 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
Weight measurements
Measured: Between Baseline and 3 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
BMI
Measured: Between Baseline and 3 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
weight measurements
Measured: Between Baseline and 6 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
BMI
Measured: Between Baseline and 6 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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
Measured: At 3 months
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
Measured: At 6 months
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
Measured: At 3 months
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 :
- average compliance
- AHI apnea hypopnea index (number per hour)
- leakage
- respiratory frequency (number per minute)
- tidal volume
- percentage of triggered cycles.
Measured: At 6 months
Evaluation of the NIV parameters between the 2 groups at 3 months
NIV parameters obtained using data from the machine report :
- expiratory pressure (cmH²O)
- inspiratory pressure (cmH²O)
- respiratory rate (number per minute)
- minimum and maximum inspiratory time (seconde)
- inspiratory and expiratory trigger
- inspiratory and expiratory slope
Measured: At 3 months
Evaluation of the NIV parameters between the 2 groups at 6 months
NIV parameters obtained using data from the machine report
Measured: At 6 months
Evaluation of survival between the 2 groups at 3 months
Evaluation of survival between the 2 groups at 3 months
Measured: At 3 months
Evaluation of survival between the 2 groups at 6 months
Evaluation of survival between the 2 groups at 6 months
Measured: At 6 months
Evaluation of time to first hospitalization between the 2 groups at 3 months
recovery of hospitalization data
Measured: At 3 months
Evaluation of time to first hospitalization between the 2 groups at 6 months
recovery of hospitalization data
Measured: At 6 months
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 rated from 0 (most dissatisfied) to 100 (extremely satisfied)
Measured: At 3 months
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
Measured: At 6 months
Medico-economic evaluation: incremental cost-utility ratio
Utility will be derived from the EQ5D
Measured: 6 months
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
Measured: At 3 months
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
Measured: At 6 months
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
Measured: At 3 months
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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 Jul 2023
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Why it stopped: lack of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, two-armed, interventional controlled study versus multicenter, open-label study.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Francois BUGHIN, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837507
- Sponsor's protocol ID
- RECHMPL23_0054
- Acronym
- ANEX
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05837507
- Acronym / sponsor ID
- ANEX / RECHMPL23_0054
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis (ALS), Non invasive ventilation, Telemonitoring, Telemedicine, Multidisciplinary approach
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitement
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, two-armed, interventional controlled study versus multicenter, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Telerehabilitation solution (m-Rehab), Other: Usual management including NIV.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. |
| Control Comparator | Active comparator | Other: Usual management including NIV.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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation solution (m-Rehab)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. | Other | Experimental |
| Usual management including NIV.Usual management including NIV. | Other | Control Comparator, Experimental |
Primary outcome
Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
Time frame: Between baseline and 6 months
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
35 secondary outcomes
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).
Time frame: Between 3 months and 6 months
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).
Time frame: Between Baseline and 3 months
Evolution of dyspnea between the 2 groups between baseline and 3 months
Time frame: Between Baseline and 3 months
Evolution of dyspnea between the 2 groups between baseline and 6 months
Time frame: Between Baseline and 6 months
Evolution of Quality of life between the 2 groups between baseline and 3 months
Time frame: Between Baseline and 3 months
Evolution of Quality of life between the 2 groups between baseline and 6 months
Time frame: Between Baseline and 6 months
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months
Time frame: Between Baseline and 3 months
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months
Time frame: Between Baseline and 6 months
Evolution of Patient satisfaction between the 2 groups between baseline and 3 months
Time frame: Between Baseline and 3 months
Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months
Time frame: Between Baseline and 3 months
Evolution of Patient satisfaction between the 2 groups between baseline and 6 months
Time frame: Between Baseline and 6 months
Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months
Time frame: Between Baseline and 6 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
Time frame: Between Baseline and 3 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
Time frame: Between Baseline and 3 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
Time frame: Between Baseline and 6 months
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
Time frame: Between Baseline and 6 months
Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months
Time frame: At 3 months
Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months
Time frame: At 6 months
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry
Time frame: At 3 months
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry
Time frame: At 6 months
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography
Time frame: At 3 months
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography
Time frame: At 6 months
Evaluation of the NIV parameters between the 2 groups at 3 months
Time frame: At 3 months
Evaluation of the NIV parameters between the 2 groups at 6 months
Time frame: At 6 months
Evaluation of survival between the 2 groups at 3 months
Time frame: At 3 months
Evaluation of survival between the 2 groups at 6 months
Time frame: At 6 months
Evaluation of time to first hospitalization between the 2 groups at 3 months
Time frame: At 3 months
Evaluation of time to first hospitalization between the 2 groups at 6 months
Time frame: At 6 months
Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution
Time frame: At 3 months
Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution
Time frame: At 6 months
Medico-economic evaluation: incremental cost-utility ratio
Time frame: 6 months
Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution
Time frame: At 3 months
Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution
Time frame: At 6 months
Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution
Time frame: At 3 months
Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois BUGHIN, MD study director
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation solution (m-Rehab) and Usual management including NIV. in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up. (time frame: Between baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.