Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

NCT06286917 | Recruiting

• 1 other identifier: R24001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Respiratory Failure; Ventilation Therapy; ALS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS

  5 years

Study Arms (2)

NIV initiation in outpatient clinic in patients with ALS

ACTIVE COMPARATOR

Starting the NIV at the outpatient clinic

Other: NIV initiation in patients with ALS

NIV initiation in pulmonary ward in patients with ALS

ACTIVE COMPARATOR

Starting the NIV in the pulmonary ward

Other: NIV initiation in patients with ALS

Interventions

NIV initiation in patients with ALS OTHER

NIV initiation according to standard care

NIV initiation in outpatient clinic in patients with ALS; NIV initiation in pulmonary ward in patients with ALS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALS diagnosed by a neurology and
• chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

RECRUITING

Central Study Contacts

Heidi A Rantala, MD, PhD

CONTACT

+3583311611; heidi.rantala@tuni.fi

Hanna Korkeamäki, MD, MSc

CONTACT

+3583311611; hanna.korkeamaki@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 29, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)