Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

NCT ID: NCT06286917

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Ventilation Therapy ALS Chronic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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NIV initiation in outpatient clinic in patients with ALS

Starting the NIV at the outpatient clinic

Group Type ACTIVE_COMPARATOR

NIV initiation in patients with ALS

Intervention Type OTHER

NIV initiation according to standard care

NIV initiation in pulmonary ward in patients with ALS

Starting the NIV in the pulmonary ward

Group Type ACTIVE_COMPARATOR

NIV initiation in patients with ALS

Intervention Type OTHER

NIV initiation according to standard care

Interventions

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NIV initiation in patients with ALS

NIV initiation according to standard care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role lead

Responsible Party

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Heidi Rantala

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Heidi A Rantala, MD, PhD

Role: CONTACT

+3583311611

Hanna Korkeamäki, MD, MSc

Role: CONTACT

+3583311611

Facility Contacts

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Heidi A Rantala, MD, PhD

Role: primary

+3583311611

Lauri Lehtimäki, MD, PhD

Role: backup

+3583311611

Other Identifiers

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R24001

Identifier Type: -

Identifier Source: org_study_id

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