NCT Number: NCT03130361
Wearable Noninvasive Positive Pressure Ventilation Device in 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.
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Notify MeKey information
Conditions
Age range
35 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Dr Michèle Bognie Pneumology Office, Alès, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with stable severe COPD (with FEV1 ≤50% predicted)
- Patients with mMRC score > ou = 2.
Exclusion criteria
- 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.
- 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.
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
Change of Baseline Dyspnea Index (BDI) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
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.
-
Change of Modified Medical Research Council Questionnaire (mMRC) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
The mMRC is one of dyspnea parameters
-
Change of Transition Dyspnea Index (TDI)
Time frame: baseline and post use of the Vitabreath device at 4th weeks
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).
-
Subjective appréciation of the device
Time frame: post use of the Vitabreath device at 4th weeks
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
-
Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
Time frame: baseline and post use of the Vitabreath device at 4th weeks
The VRSQ represents health related quality of life of COPD patients
-
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
The CAT represents health related quality of life of COPD patients
Other outcomes
-
Compliance to the device
Time frame: Every week over the 4-week period
During a weekly phone call, patients will indicate the daily duration and conditions of use of the device
-
Number of acute exacerbation
Time frame: Up to 12 months before the date of inclusion
Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation.
-
Weight
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Patient will indicate their weight
Sponsors and collaborators
Lead sponsor
Icadom
Industry
Collaborators
- Philips Respironics
Registry information
Official study title
Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
Acronym: VITABREATH
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 26, 2017
- Registry last updated
- Oct 3, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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