Amyotrophic Lateral SclerosisNCT05829330
Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation
A study testing Outpatient and Hospitalization in people with Amyotrophic Lateral Sclerosis, run by Anne Kathrine Staehr-Rye at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Outpatient and Hospitalization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosed with amyotrophic lateral sclerosis
- Indication for start of non-invasive mechanical ventilation
Who cannot join
- No informed consent
- Does not understand Danish or English
- Indication for invasive mechanical ventilation
- No morning baseline PCO2
- Hospitalization
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia, Pain and REspiratory Support
Glostrup Municipality, 2600
About this study
Official title: Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Outpatient, Hospitalization
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientOther
Outpatient Initiation of noninvasive mechanical ventilation
HospitalizationOther
Initiation of non-invasive mechanical ventilation during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Outpatient | Active comparator | Outpatient initiation of non-invasive mechanical ventilation Receives: Other: Outpatient |
| Hospitalization | Placebo comparator | Initiation of non-invasive mechanical ventilation during hospitalization Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of non-invasive mechanical ventilation
Use of non-invasive mechanical ventilation in minutes per day
Measured: The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Secondary outcomes (2)
Patient satisfaction with the treatment
Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)
Measured: Measured at the 3 months follow-up visit
Patient satisfaction with the proces in relation to the start of the treatment
Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)
Measured: Measured at the 3 months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start20 Sep 2023
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Kathrine Staehr-Rye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Kathrine Staehr-Rye, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829330
- Sponsor's protocol ID
- H-23005093
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stokholm JB, Kuchen SHL, Moller K, Gatke MR, Svenstrup K, Staehr-Rye AK. Outpatient versus inpatient initiation of home mechanical ventilation in patients with amyotrophic lateral sclerosis - a protocol for a randomised trial. Dan Med J. 2026 Mar 19;73(4):A09250733. doi: 10.61409/A09250733.
PubMed 41978444
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
- ClinicalTrials.gov ID
- NCT05829330
- Acronym / sponsor ID
- H-23005093
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Anne Kathrine Staehr-RyeUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Active comparator | Other: OutpatientOutpatient initiation of non-invasive mechanical ventilation |
| Hospitalization | Placebo comparator | Other: HospitalizationInitiation of non-invasive mechanical ventilation during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosed with amyotrophic lateral sclerosis
- Indication for start of non-invasive mechanical ventilation
Key exclusion criteria (5 listed)
- No informed consent
- Does not understand Danish or English
- Indication for invasive mechanical ventilation
- No morning baseline PCO2
- Hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutpatientOutpatient Initiation of noninvasive mechanical ventilation | Other | Outpatient |
| HospitalizationInitiation of non-invasive mechanical ventilation during hospitalization | Other | Hospitalization |
Primary outcome
Use of non-invasive mechanical ventilation
Time frame: The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Use of non-invasive mechanical ventilation in minutes per day
2 secondary outcomes
Patient satisfaction with the treatment
Time frame: Measured at the 3 months follow-up visit
Patient satisfaction with the proces in relation to the start of the treatment
Time frame: Measured at the 3 months follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 41978444Stokholm JB, Kuchen SHL, Moller K, Gatke MR, Svenstrup K, Staehr-Rye AK. Outpatient versus inpatient initiation of home mechanical ventilation in patients with amyotrophic lateral sclerosis - a protocol for a randomised trial. Dan Med J. 2026 Mar 19;73(4):A09250733. doi: 10.61409/A09250733.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient and Hospitalization in people with Amyotrophic Lateral Sclerosis, run by Anne Kathrine Staehr-Rye at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of non-invasive mechanical ventilation (time frame: The 83th to the 90th day after initiation of non-invasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.