Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

ALS Clinical Trial

— InNIVALS  

Official title:

Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286917
• Other study ID #: R24001
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: Tampere University
• Contact: Heidi A Rantala, MD, PhD
• Phone: +3583311611
• Email: heidi.rantala[@]tuni.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• ALS diagnosed by a neurology and

• chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

Exclusion Criteria:

• impaired cognition to give informed consent to participation

• contraindication to NIV therapy

• another severe disease with a prognosis of less than one year

• ventilation via an artificial airway, tracheostomy

Related Conditions & MeSH terms

• ALS
• Chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• NIV initiation in patients with ALS
NIV initiation according to standard care

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS	How much does the initiation of NIV cost in outpatient setting compared with initiation in a pulmonary ward including all the contacts with a nurse and a doctor during the following year after the initiation.	5 years
Primary	NIV usage hours according to different initiation locations in patients with ALS	NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)	5 years
Primary	Compliance with NIV according to NIV initiation setting in patients with ALS	Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.	5 years
Primary	Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.	The effectiveness of the treatment on the reduction of blood carbon dioxide pressure	5 years