Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency (InNIVALS)

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.

Study Overview

• Status: Recruiting
• Conditions: ALS; Chronic Respiratory Failure; Ventilation Therapy
• Intervention / Treatment: Other: NIV initiation in patients with ALS

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi A Rantala, MD, PhD; Phone Number: +3583311611; Email: heidi.rantala@tuni.fi
• Study Contact Backup: Name: Hanna Korkeamäki, MD, MSc; Phone Number: +3583311611; Email: hanna.korkeamaki@pirha.fi

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Recruiting
    • Tampere University Hospital
    • Contact: Heidi A Rantala, MD, PhD; Phone Number: +3583311611; Email: heidi.rantala@tuni.fi
    • Contact: Lauri Lehtimäki, MD, PhD; Phone Number: +3583311611; Email: lauri.lehtimaki@tuni.fi
    • Principal Investigator: Hanna Korkeamäki, MD, MSc
    • Sub-Investigator: Hannele Hasala, MD, PhD
    • Sub-Investigator: Sirpa Leivo-Korpela, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIV initiation in outpatient clinic in patients with ALS; Starting the NIV at the outpatient clinic	Other: NIV initiation in patients with ALS; NIV initiation according to standard care
Active Comparator: NIV initiation in pulmonary ward in patients with ALS; Starting the NIV in the pulmonary ward	Other: NIV initiation in patients with ALS; NIV initiation according to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: R24001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No