Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome (OVNI-Dom)

August 5, 2015 updated by: IP Santé Domicile

Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study

The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Overlap Syndrome is defined by the coexistence of chronic obstructive pulmonary disease (COPD) and an apnea - hypopnea syndrome obstructive sleep (SAHS). The interaction between these two diseases is responsible for deepest nocturnal desaturation, decreased sensitivity to CO2, more pronounced sleep alterations, more frequent daytime hypercapnia, a higher risk of hypertension pulmonary and increased cardiovascular risk, compared to subjects with COPD or isolated SAHS.

The Overlap Syndrome treatments are continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV), associated complemented or not by oxygen therapy during sleep. The criteria for choosing the type of treatment are not well defined. Quality and compliance of the NIV are very important in all diseases leading to chronic respiratory failure whose Overlap Syndrome. The increase in the number of patients treated with NIV is estimated at over 12% per year. The NIV startup is usually performed in a conventional hospitalization but congestion healthcare pathways lead to increase waiting time before treatment. Thus, to date, no study has validated a supported alternative to meet the increase in the number of patients on NIV while maintaining quality service.

The HAS has defined good candidates for a NIV home based startup, on the following criteria: patients with a recognized indication of NIV in the long term , with stable respiratory failure, requiring only nocturnal ventilation, surrounded by caregivers mastering the use of equipment and whose location allows rapid intervention. The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Annecy, France, 74374
      • Bordeaux, France, 33073
      • Cannes, France, 06401
        • Not yet recruiting
        • Ch Cannes
        • Contact:
      • Dijon, France, 21000
      • Foix, France, 09017
      • Garches, France, 92380
        • Not yet recruiting
        • Hôpital Raymond Poincaré
        • Contact:
      • Grenoble, France, 38043
        • Not yet recruiting
        • CHU de Grenoble site Nord - Hôpital Albert Michallon
        • Contact:
      • Haguenau, France, 67500
        • Not yet recruiting
        • Centre Hospitalier Haguenau
        • Contact:
          • Parisa ASSEMI, MD
          • Phone Number: 03 88 06 33 33
      • Lesparre, France, 33340
        • Not yet recruiting
        • Clinique Mutualiste du Medoc
        • Contact:
      • Lille, France, 59037
      • Paris, France, 75018
      • Paris, France, 75651
        • Not yet recruiting
        • CHU la Pitié-Salpétrière
        • Contact:
        • Principal Investigator:
          • Jésus Gonzalez, MD
      • Rennes, France, 35700
        • Recruiting
        • Clinique Saint Laurent
        • Contact:
      • Saint Laurent du Var, France, 06721
        • Not yet recruiting
        • Institut Arnault Tzanck
        • Contact:
      • Strasbourg, France, 67091
      • Toulouse, France, 31053
        • Not yet recruiting
        • Hopital Larrey CHU Toulouse
        • Contact:
      • le Blanc Mesnil, France, 93150
        • Recruiting
        • Clinique Du Blanc Mesnil
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major patients, of less than 80 years
  • Patients with chronic respiratory failure within a Overlap syndrome ( defined by the coexistence of COPD and OAS ) in stable situation (no exacerbation for at least 4 weeks) , indication for a NIV treatment
  • OAS confirmed by polysomnography according to the standards of the American Academy of Sleep Medicine ( AASM ) with an AHI> 15, the central apneas are tolerated if < 20%
  • COPD defined by obstruction of the air flow : VEMS/CVF <70 % and VEMS <80% of the average value predicted
  • Started criteria of NIV: chronic respiratory failure within an Overlap Syndrome and PaCO2 > 45 mmHg (at rest on room air ) and / or medium PtCO2 > 50 mmHg
  • Patient informed of the study and who signed an informed consent

Exclusion Criteria:

  • Patients already treated for OAS in the year
  • Patient tracheotomised
  • Other diseases with respiratory involvement : neuromuscular disease , restrictive disease of the chest with CPT <80% , apnea syndrome pure central sleep ( central apnea are tolerated if < 20% )
  • Lung cancer within the last 5 years
  • Uncontrolled psychic diseases
  • Acute respiratory failure requiring NIV , going back a month
  • Clinical situation requiring prolonged hospitalization
  • Patients with no opportunity to understand and follow instructions
  • Refusal to participate in the study
  • Lack of insurance coverage
  • Pregnant and / or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IniVAH
Initiation of the NIV in hospital : current care. 3 days hospitalization to start-up the NIV as usual.
Other: IniVAH
Initiation of the NIV during a 3 days hospitalization as usual.
Other Names:
  • Initiation of the NIV at hospital : current care
EXPERIMENTAL: IniVAD
Initiation of the NIV at home : experimental care.
Other: IniVAD
Initiation of the NIV at home. The first day, the kinesiologist and the technician start-up the NIV at home with the patient. The investigator will validate the adjustment settings proposed by the kinesiologist. No procedure during the second day as described by the HAS. The third day, the kinesiologist and the technician come back to the patient home so as to adjust the settings if needed and if validated by the investigator.
Other Names:
  • Initiation of the NIV at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compliance- average adherence measured over the three months under NIV expressed in hours/night
Time Frame: month 3 (M3)
month 3 (M3)

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3
Time Frame: month 3 (M3)
month 3 (M3)
quality of life and satisfaction of the patients : patient life satisfaction questionnaire
Time Frame: month 3 (M3)
month 3 (M3)
the occurrence of complications : number of NIV complication occurred
Time Frame: month 3
month 3
economic study- number of hospitalization nights
Time Frame: month 3 (M3)
month 3 (M3)
economic study- number of intervention of the kinesiologist and the technician
Time Frame: month 3 (M3)
month 3 (M3)
economic study- number of phone contact by the patient
Time Frame: month 3 (M3)
month 3 (M3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IP Santé Domicile

Investigators

  • Study Director: Safia Maaradji-Gati, MD, IPSanté Domicile
  • Principal Investigator: Jésus Gonzalez, MD, La Pitié-Salpêtrière
  • Principal Investigator: Marie Pia D'orthor, MD, Hôpital Bichat - Claude Bernard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (ESTIMATE)

February 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNI_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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