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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03130361
Other study ID # 2016-A01297-44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2017
Est. completion date January 10, 2018

Study information

Verified date October 2018
Source Icadom
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 10, 2018
Est. primary completion date January 10, 2018
Accepts healthy volunteers No
Gender All
Age group 35 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Non-Invasive Ventilation


Locations

Country Name City State
France Dr Michèle Bognie Pneumology Office Alès
France Clinique du Parc Castelnau-le-Lez
France CHU Grenoble-Alpes Grenoble
France Hôpital Privé La Louvière Lille
France Dr Christian PAILLARGUELO Pneumology Office Lunel
France CHU Caremeau Nîmes
France Clinique Pasteur Toulouse

Sponsors (2)

Lead Sponsor Collaborator
Icadom Philips Respironics

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Compliance to the device During a weekly phone call, patients will indicate the daily duration and conditions of use of the device Every week over the 4-week period
Other Number of acute exacerbation Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation. Up to 12 months before the date of inclusion
Other Weight Patient will indicate their weight baseline and post use of the Vitabreath device at 4th weeks
Primary Change of daily physical activity measured by actimetry Change of number of steps by day and daily energy expenditure over the 8 week period 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 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. baseline and post use of the Vitabreath device at 4th weeks
Secondary Change of Modified Medical Research Council Questionnaire (mMRC) score The mMRC is one of dyspnea parameters baseline and post use of the Vitabreath device at 4th weeks
Secondary 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). baseline and post use of the Vitabreath device at 4th weeks
Secondary 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 post use of the Vitabreath device at 4th weeks
Secondary Change of Visual Simplified Respiratory Questionnaire (VSRQ) score The VRSQ represents health related quality of life of COPD patients baseline and post use of the Vitabreath device at 4th weeks
Secondary Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score The CAT represents health related quality of life of COPD patients 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
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