Improving quality of life for ALS patients using non-invasive ventilation
Optimizing INITIation of Non-invasive Ventilation in ALS Patients
This study is testing how non-invasive ventilation can improve the quality of life for adults with ALS and related conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05033951 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine which types of ALS patients benefit most from non-invasive ventilation (NIV) in terms of quality of life. Adult patients with ALS, PLS, or PSMA will be included during their first visit to specialized centers in the Netherlands. Participants will be divided into two cohorts: those who start NIV within two months and those who do not. The study will assess changes in quality of life using validated questionnaires over a follow-up period of nine months after NIV initiation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with ALS, PLS, or PSMA who can provide informed consent.
Not a fit: Patients currently using NIV or invasive ventilation, or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for ALS patients by identifying the most effective use of non-invasive ventilation.
How similar studies have performed: While studies on non-invasive ventilation in ALS exist, this specific approach focusing on quality of life improvements is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Diagnosis of ALS, PLS or PSMA * Ability to give informed consent. * Ability to fill in the questionnaires independently or with assistance of a caregiver. Exclusion Criteria: * Use of NIV or invasive ventilation (tracheostomy) at time of first visit to a HMV centre. * Pregnancy
Where this trial is running
Groningen
- University medical centre Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rineke Jaspers Focks, MD
- Email: r.jaspersfocks@roessingh.nl
- Phone: +31534875424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.