Wearable Noninvasive Positive Pressure Ventilation Device in COPD (VITABREATH)

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.

Study Overview

• Status: Completed
• Conditions: Non-Invasive Ventilation
• Intervention / Treatment: Device: Non-Invasive Ventilation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alès, France, 30100
    • Dr Michèle Bognie Pneumology Office
  • Castelnau-le-Lez, France, 34000
    • Clinique du parc
  • Grenoble, France, 38043
    • CHU Grenoble-Alpes
  • Lille, France, 59042
    • Hopital Privé La Louviere
  • Lunel, France, 34400
    • Dr Christian PAILLARGUELO Pneumology Office
  • Nîmes, France, 30900
    • CHU Caremeau
  • Toulouse, France, 31300
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noninvasive ventilation; 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.	Device: Non-Invasive Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Weight	Patient will indicate their weight	baseline and post use of the Vitabreath device at 4th weeks

Collaborators and Investigators

• Sponsor: Icadom
• Collaborators: Philips Respironics
• Investigators: Principal Investigator: Jean-Louis PEPIN, Pr, Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A01297-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED