Non-Invasive VentilationVITABREATHNCT03130361
Wearable Noninvasive Positive Pressure Ventilation Device in COPD
A study testing Non-Invasive Ventilation in people with Non-Invasive Ventilation, run by Icadom at 7 sites in France.
Trial summary
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Non-Invasive Ventilation
- What is being tested?
- Non-Invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesFrance
- Study dates
- 12 Jan 2017to 10 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable severe COPD (with FEV1 ≤50% predicted)
- Patients with mMRC score > ou = 2.
Who cannot join
- Exacerbate within a month prior.
- Using other non invasive ventilation device > 15h per day.
- Have musculoskeletal or neuromuscular problem affecting balance and walking.
- Have cognitive problem affecting comprehension of the different évaluations or questionnaires.
- Have recently participated in physical training or rehabilitation program (≤ 3 months).
- Medical contra-indication to NIV.
Show all 10Show fewer
- Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing).
- Simultaneously enrolled in an other clinical trial.
- Not affiliated to social security.
- Person deprived of liberty, major protected by law.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Dr Michèle Bognie Pneumology Office
Alès, 30100
Clinique du Parc
Castelnau-le-Lez, 34000
CHU Grenoble-Alpes
Grenoble, 38043
Hôpital Privé La Louvière
Lille, 59042
Dr Christian PAILLARGUELO Pneumology Office
Lunel, 34400
CHU Caremeau
Nîmes, 30900
Clinique Pasteur
Toulouse, 31300
About this study
Official title: Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
Read the detailed description
In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.
- Conditions
- Non-Invasive Ventilation
- Being tested
- Non-Invasive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive VentilationDevice
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation | Experimental | Participants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period. Receives: Device: Non-Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of daily physical activity measured by actimetry
Change of number of steps by day and daily energy expenditure over the 8 week period
Measured: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Secondary outcomes (6)
Change of Baseline Dyspnea Index (BDI) score
The BDI represents importance and impact of dyspnea in daily life of COPD patients. The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea.
Measured: baseline and post use of the Vitabreath device at 4th weeks
Change of Modified Medical Research Council Questionnaire (mMRC) score
The mMRC is one of dyspnea parameters
Measured: baseline and post use of the Vitabreath device at 4th weeks
Change of Transition Dyspnea Index (TDI)
The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea).
Measured: baseline and post use of the Vitabreath device at 4th weeks
Subjective appréciation of the device
Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life
Measured: post use of the Vitabreath device at 4th weeks
Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
The VRSQ represents health related quality of life of COPD patients
Measured: baseline and post use of the Vitabreath device at 4th weeks
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score
The CAT represents health related quality of life of COPD patients
Measured: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start12 Jan 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive VentilationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icadom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Respironics
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Pr, Principal investigator, Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130361
- Sponsor's protocol ID
- 2016-A01297-44
- Acronym
- VITABREATH
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
- ClinicalTrials.gov ID
- NCT03130361
- Acronym / sponsor ID
- VITABREATH / 2016-A01297-44
- Conditions
- Non-Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IcadomIndustry (pharma, biotech, devices)
- Collaborators
- Philips Respironics
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 26 Apr 2017 (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 objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
Detailed description
In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation | Experimental | Device: Non-Invasive VentilationParticipants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stable severe COPD (with FEV1 ≤50% predicted)
- Patients with mMRC score > ou = 2.
Key exclusion criteria (10 listed)
- Exacerbate within a month prior.
- Using other non invasive ventilation device > 15h per day.
- Have musculoskeletal or neuromuscular problem affecting balance and walking.
- Have cognitive problem affecting comprehension of the different évaluations or questionnaires.
- Have recently participated in physical training or rehabilitation program (≤ 3 months).
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 |
|---|---|---|
| Non-Invasive Ventilation | Device | Noninvasive ventilation |
Primary outcome
Change of daily physical activity measured by actimetry
Time frame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Change of number of steps by day and daily energy expenditure over the 8 week period
6 secondary outcomes
Change of Baseline Dyspnea Index (BDI) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Modified Medical Research Council Questionnaire (mMRC) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Transition Dyspnea Index (TDI)
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Subjective appréciation of the device
Time frame: post use of the Vitabreath device at 4th weeks
Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score
Time frame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
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 3 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Invasive Ventilation
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Not yet recruiting
Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers
Healthy Adult, Cardiac Output
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.
Jean-Louis PEPIN, Pr principal investigator
Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Ventilation in people with Non-Invasive Ventilation, run by Icadom at 7 sites in France.
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 10 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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 of daily physical activity measured by actimetry (time frame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device). 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 3 Oct 2018.