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Completed

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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Key information

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

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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

Non-invasive ventilation

Device

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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).

  4. 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

  5. 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

  6. 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

  1. 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

  2. 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.

  3. 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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