Ventilation TherapyInNIVALSNCT06286917
Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
A study testing NIV initiation in patients with ALS in people with Ventilation Therapy and ALS, run by Tampere University at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ventilation Therapy, ALS, Chronic Respiratory Failure
- What is being tested?
- NIV initiation in patients with ALS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 5 Mar 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALS diagnosed by a neurology and
- chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Ventilation Therapy, ALS, Chronic Respiratory Failure
- Being tested
- NIV initiation in patients with ALS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV initiation in patients with ALSOther
NIV initiation according to standard care
| Study group | Role | What they receive |
|---|---|---|
| NIV initiation in outpatient clinic in patients with ALS | Active comparator | Starting the NIV at the outpatient clinic Receives: 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 Receives: Other: NIV initiation in patients with ALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start5 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation TherapyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Rantala, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286917
- Sponsor's protocol ID
- R24001
- Acronym
- InNIVALS
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT06286917
- Acronym / sponsor ID
- InNIVALS / R24001
- Conditions
- Ventilation Therapy, ALS, Chronic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Feb 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV initiation in outpatient clinic in patients with ALS | Active comparator | Other: NIV initiation in patients with ALSStarting the NIV at the outpatient clinic |
| NIV initiation in pulmonary ward in patients with ALS | Active comparator | Other: NIV initiation in patients with ALSStarting the NIV in the pulmonary ward |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ALS diagnosed by a neurology and
- chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| NIV initiation in patients with ALSNIV initiation according to standard care | Other | NIV initiation in outpatient clinic in patients with ALS, NIV initiation in pulmonary ward in patients with ALS |
Primary outcome
NIV usage hours according to different initiation locations in patients with ALS
Time frame: 5 years
NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)
Compliance with NIV according to NIV initiation setting in patients with ALS
Time frame: 5 years
Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.
Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.
Time frame: 5 years
The effectiveness of the treatment on the reduction of blood carbon dioxide pressure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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 NIV initiation in patients with ALS in people with Ventilation Therapy and ALS, run by Tampere University at 1 site in Finland.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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 Finland. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
NIV usage hours according to different initiation locations in patients with ALS (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.