NCT03130361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

August 16, 2016

Last Update Submit

October 1, 2018

Conditions

Non-Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change of Baseline Dyspnea Index (BDI) score

    baseline and post use of the Vitabreath device at 4th weeks

  • Change of Modified Medical Research Council Questionnaire (mMRC) score

    baseline and post use of the Vitabreath device at 4th weeks

  • Change of Transition Dyspnea Index (TDI)

    baseline and post use of the Vitabreath device at 4th weeks

  • Subjective appréciation of the device

    post use of the Vitabreath device at 4th weeks

  • Change of Visual Simplified Respiratory Questionnaire (VSRQ) score

    baseline and post use of the Vitabreath device at 4th weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Compliance to the device

    Every week over the 4-week period

  • Number of acute exacerbation

    Up to 12 months before the date of inclusion

  • Weight

    baseline and post use of the Vitabreath device at 4th weeks

Study Arms (1)

Noninvasive ventilation

EXPERIMENTAL

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

Interventions

Non-Invasive VentilationDEVICE
Noninvasive ventilation

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable severe COPD (with FEV1 ≤50% predicted)
  • Patients with mMRC score \> ou = 2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dr Michèle Bognie Pneumology Office

Alès, 30100, France

Location

Clinique du Parc

Castelnau-le-Lez, 34000, France

Location

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

Hôpital Privé La Louvière

Lille, 59042, France

Location

Dr Christian PAILLARGUELO Pneumology Office

Lunel, 34400, France

Location

CHU Caremeau

Nîmes, 30900, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jean-Louis PEPIN, Pr

    Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

April 26, 2017

Study Start

January 12, 2017

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

FR(7)