Amyotrophic Lateral Sclerosis (ALS)NCT02537132
"New Perspectives of Adaptation to NIV in ALS"
A study testing Adaptation and training to Non Invasive Ventilation (NIV) in people with Amyotrophic Lateral Sclerosis (ALS), run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
Trial summary
The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Adaptation and training to Non Invasive Ventilation (NIV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2015to Jan 2018
- 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
- ALS diagnosis according to the criteria of El Escorial;
- Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
- No respiratory infection within 3 months
- Severe disability (ALS-FRS <31);
- Age > 18 years;
- The voluntary participation to the Study.
Who cannot join
- -- Previous episodes of pneumothorax;
- Comorbid cardiac and / or renal important
- Severe cognitive impairment;
- Refusal of the patient at the time of Informed Consent.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: "New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Adaptation and training to Non Invasive Ventilation (NIV)
- Keywords
- Non Invasive Ventilation (NIV), Amyotrophic Lateral sclerosis (ALS), adaptation, home care
- 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.
Adaptation and training to Non Invasive Ventilation (NIV)Other
Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| Home Group | Experimental | Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home Receives: Other: Adaptation and training to Non Invasive Ventilation (NIV) |
| Outpatient Group | Active comparator | Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic Receives: Other: Adaptation and training to Non Invasive Ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
Measured: Baseline + after 2 and 4 months from the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537132
- Sponsor's protocol ID
- FDG_ALS1H_01
- Status last verified
- Jul 2018
- First submitted
- 28 Aug 2015
- Last updated
- 2 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
- ClinicalTrials.gov ID
- NCT02537132
- Acronym / sponsor ID
- FDG_ALS1H_01
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Non Invasive Ventilation (NIV), Amyotrophic Lateral sclerosis (ALS), adaptation, home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2018
- First posted
- 1 Sep 2015 (estimated)
- 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 study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Group | Experimental | Other: Adaptation and training to Non Invasive Ventilation (NIV)Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home |
| Outpatient Group | Active comparator | Other: Adaptation and training to Non Invasive Ventilation (NIV)Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ALS diagnosis according to the criteria of El Escorial;
- Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
- No respiratory infection within 3 months
- Severe disability (ALS-FRS <31);
- Age > 18 years;
Key exclusion criteria (4 listed)
- -- Previous episodes of pneumothorax;
- Comorbid cardiac and / or renal important
- Severe cognitive impairment;
- Refusal of the patient at the time of Informed Consent.
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 |
|---|---|---|
| Adaptation and training to Non Invasive Ventilation (NIV)Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition. | Other | Home Group, Outpatient Group |
Primary outcome
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
Time frame: Baseline + after 2 and 4 months from the recruitment
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
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 2 Aug 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptation and training to Non Invasive Ventilation (NIV) in people with Amyotrophic Lateral Sclerosis (ALS), run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
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 6 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: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
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?
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV) (time frame: Baseline + after 2 and 4 months from the recruitment). 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 2 Aug 2018.