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Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

NCT ID: NCT05829330

Last Updated: 2025-12-18

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2026-04-30

Brief Summary

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The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital

The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Outpatient

Outpatient initiation of non-invasive mechanical ventilation

Group Type ACTIVE_COMPARATOR

Outpatient

Intervention Type OTHER

Outpatient Initiation of noninvasive mechanical ventilation

Hospitalization

Initiation of non-invasive mechanical ventilation during hospitalization

Group Type PLACEBO_COMPARATOR

Hospitalization

Intervention Type OTHER

Initiation of non-invasive mechanical ventilation during hospitalization

Interventions

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Outpatient

Outpatient Initiation of noninvasive mechanical ventilation

Intervention Type OTHER

Hospitalization

Initiation of non-invasive mechanical ventilation during hospitalization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Diagnosed with amyotrophic lateral sclerosis
* Indication for start of non-invasive mechanical ventilation

Exclusion Criteria

* No informed consent
* Does not understand Danish or English
* Indication for invasive mechanical ventilation
* No morning baseline PCO2
* Hospitalization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anne Kathrine Staehr-Rye

OTHER

Sponsor Role lead

Responsible Party

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Anne Kathrine Staehr-Rye

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Anaesthesia, Pain and REspiratory Support

Glostrup Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anne Kathrine Staehr-Rye, MD

Role: CONTACT

Phone: 004538683868

Email: [email protected]

Facility Contacts

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Anne Kathrine Staehr-Rye

Role: primary

Other Identifiers

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H-23005093

Identifier Type: -

Identifier Source: org_study_id