Wearable Noninvasive Positive Pressure Ventilation Device in COPD

Non-Invasive Ventilation Clinical Trial

— VITABREATH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130361
• Other study ID #: 2016-A01297-44
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Non-Invasive Ventilation

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