Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

Not Applicable

Recruiting

• Conditions: Ventilation Therapy; Chronic Respiratory Failure; ALS
• Interventions: Other: NIV initiation in patients with ALS

• Registration Number: NCT06286917
• Lead Sponsor: Tampere University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Study Start: 2024-03-05
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV initiation in outpatient clinic in patients with ALS	NIV initiation in patients with ALS	Starting the NIV at the outpatient clinic
NIV initiation in pulmonary ward in patients with ALS	NIV initiation in patients with ALS	Starting the NIV in the pulmonary ward

Primary Outcome Measures

Name	Time	Method
Compliance with NIV according to NIV initiation setting in patients with ALS	5 years	Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.
NIV usage hours according to different initiation locations in patients with ALS	5 years	NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)
Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.	5 years	The effectiveness of the treatment on the reduction of blood carbon dioxide pressure

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland