Actively Recruiting
Optimizing INITIation of Non-invasive Ventilation in ALS Patients
Led by University Medical Center Groningen · Updated on 2024-05-16
250
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective: The primary objective in this study is to identify which (pheno)type of ALS patient has the most benefit from NIV in improving quality of life. Study population: Adult patients with ALS, PLS (Primary Lateral Sclerosis) of PSMA (Progressive Spinal Muscular Atrophy) in the Netherlands. Patients will be included during their first visit to one of the HMV centres in the Netherlands. Main study parameters/endpoints: The main study parameter is change in Quality of Life (QoL) defined as change in ALS Assessment Questionnaire (ALSAQ-40) in patients with ALS after initiation of NIV. Design: Multi-centre prospective cohort study consisting of 2 non-randomized cohorts, i.e. ALS patients who start NIV and ALS patients who do not start NIV at the time of inclusion in the present study. Duration: The total duration of the study: 3,5 years. Inclusion period: 30 months. Follow up time after initiation of NIV: 9 months. Thereafter, 6 months will be used for data analysis. Setting: Involvement of all (4) HMV centres in the Netherlands (Groningen, Maastricht, Rotterdam, Utrecht). Procedure: 250 ALS patients will be included. During the first regular visit to the HMV centre patients will be asked to participate in the study. Data will be recorded during regular visits to the HMV centre.
CONDITIONS
Official Title
Optimizing INITIation of Non-invasive Ventilation in ALS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Diagnosis of ALS, PLS or PSMA
- Ability to give informed consent
- Ability to fill in questionnaires independently or with assistance of a caregiver
You will not qualify if you...
- Use of NIV or invasive ventilation (tracheostomy) at time of first visit to a HMV centre
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University medical centre Groningen
Groningen, Netherlands, 9700RB
Actively Recruiting
Research Team
R
Rineke Jaspers Focks, MD
CONTACT
P
Peter Wijkstra, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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