Overlap SyndromeOVNI-DomNCT02363413
Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome
A study testing IniVAH and IniVAD in people with Overlap Syndrome, run by IP Santé Domicile at 17 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overlap Syndrome
- What is being tested?
- IniVAH and IniVAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 17 sitesFrance
- Study dates
- Feb 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
CH Annecy-Genevois
Annecy, 74374
Taoufik DIDI, MD, 04 50 63 66 03, tdidi@ch-annecygenevois.fr
- Recruiting
Clinique Chirurgicale Bel-Air
Bordeaux, 33073
Nathalie RAYMOND, MD, 05 56 73 11 64, drraymond.nathalie@orange.fr
- Not yet recruiting
CH Cannes
Cannes, 06401
Christophe PERRIN, MD, 06 79 57 51 33, C.PERRIN@ch-cannes.fr
- Not yet recruiting
CHU Dijon
Dijon, 21000
Claudio RABEC, MD, 06 62 28 11 92, claudio.rabec@chu-dijon.fr
- Not yet recruiting
CH Intercommunal du Val d'Ariège
Foix, 09017
Abdelkader GHAZI, MD, 05 61 03 31 30, abdelkader.ghazi@chi-val-ariege.fr
- Not yet recruiting
Hôpital Raymond Poincaré
Garches, 92380
David ORLIKOWSKI, MD, 01 47 10 77 52, david.orlikowski@aphp.fr
- Not yet recruiting
CHU de Grenoble site Nord - Hôpital Albert Michallon
Grenoble, 38043
Jean-louis PEPIN, MD, 04 76 76 92 65, JPepin@chu-grenoble.fr
- Not yet recruiting
Centre Hospitalier Haguenau
Haguenau, 67500
Parisa ASSEMI, MD, 03 88 06 33 33
- Recruiting
Clinique Du Blanc Mesnil
Le Blanc-Mesnil, 93150
Naim FOURAR, MD, 06 50 60 16 69, naimfourar@hotmail.fr
- Not yet recruiting
Clinique Mutualiste du Medoc
Lesparre-Médoc, 33340
Nathalie RAYMOND, MD, 05 56 73 11 64, drraymond.nathalie@orange.fr
- Not yet recruiting
CHR - Hôpital Calmette
Lille, 59037
Stéphanie FRY, MD, 03 20 44 5948, Stephanie.POUWELS@CHRU-LILLE.FR
- Recruiting
CHU Bichat - Claude Bernard
Paris, 75018
Marie Pia d'ORTHO, MD, 01 40 25 84 01, marie-pia.dortho@bch.aphp.fr
- Not yet recruiting
CHU La Pitié-salpétrière
Paris, 75651
Jésus GONZALEZ, MD, 06 65 63 59 36, jesus.gonzalez@psl.aphp.fr
Jésus Gonzalez, MD
- Recruiting
Clinique Saint Laurent
Rennes, 35700
Arnaud PRIGENT, MD, 02 99 38 33 69, prigent@icloud.com
- Not yet recruiting
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06721
Guy-René BOYER, MD, 04 92 27 38 72, guyboyer@wanadoo.fr
- Not yet recruiting
CHU de Strasbourg - Hôpital Civil
Strasbourg, 67091
Romain KESSLER, MD, 06 60 27 48 90, romain.kessler@chru-strasbourg.fr
- Not yet recruiting
Hôpital Larrey CHU Toulouse
Toulouse, 31053
Kamila SEDKAOUI, MD, 05 67 77 18 32, sedkaoui.k@chu-toulouse.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Overlap Syndrome
- Being tested
- IniVAH, IniVAD
- Keywords
- NIV, Overlap Syndrom, home, hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IniVAHOther
Also called Initiation of the NIV at hospital : current care
Initiation of the NIV during a 3 days hospitalization as usual.
IniVADOther
Also called Initiation of the NIV at home
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.
| Study group | Role | What they receive |
|---|---|---|
| IniVAH | Active comparator | Initiation of the NIV in hospital : current care. 3 days hospitalization to start-up the NIV as usual. Receives: Other: IniVAH |
| IniVAD | Experimental | Initiation of the NIV at home : experimental care. Receives: Other: IniVAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance- average adherence measured over the three months under NIV expressed in hours/night
Measured: month 3 (M3)
Secondary outcomes (6)
quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3
Measured: month 3 (M3)
quality of life and satisfaction of the patients : patient life satisfaction questionnaire
Measured: month 3 (M3)
the occurrence of complications : number of NIV complication occurred
Measured: month 3
economic study- number of hospitalization nights
Measured: month 3 (M3)
economic study- number of intervention of the kinesiologist and the technician
Measured: month 3 (M3)
economic study- number of phone contact by the patient
Measured: month 3 (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overlap SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IP Santé Domicile
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Safia Maaradji-Gati, MD, Study director, IPSanté DomicileJésus Gonzalez, MD, Principal investigator, La Pitié-SalpétrièreMarie Pia D'orthor, MD, Principal investigator, Hôpital Bichat - Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363413
- Sponsor's protocol ID
- VNI_001
- Acronym
- OVNI-Dom
- Status last verified
- Aug 2015
- First submitted
- 27 Jan 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study
- ClinicalTrials.gov ID
- NCT02363413
- Acronym / sponsor ID
- OVNI-Dom / VNI_001
- Conditions
- Overlap Syndrome
- Keywords
- NIV, Overlap Syndrom, home, hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IP Santé DomicileIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IniVAH | Active comparator | Other: IniVAHInitiation of the NIV in hospital : current care. 3 days hospitalization to start-up the NIV as usual. |
| IniVAD | Experimental | Other: IniVADInitiation of the NIV at home : experimental care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IniVAHAlso: Initiation of the NIV at hospital : current careInitiation of the NIV during a 3 days hospitalization as usual. | Other | IniVAH |
| IniVADAlso: Initiation of the NIV at homeInitiation 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 | IniVAD |
Primary outcome
compliance- average adherence measured over the three months under NIV expressed in hours/night
Time frame: month 3 (M3)
6 secondary outcomes
quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3
Time frame: month 3 (M3)
quality of life and satisfaction of the patients : patient life satisfaction questionnaire
Time frame: month 3 (M3)
the occurrence of complications : number of NIV complication occurred
Time frame: month 3
economic study- number of hospitalization nights
Time frame: month 3 (M3)
economic study- number of intervention of the kinesiologist and the technician
Time frame: month 3 (M3)
economic study- number of phone contact by the patient
Time frame: month 3 (M3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safia Maaradji-Gati, MD study director
IPSanté Domicile
Jésus Gonzalez, MD principal investigator
La Pitié-Salpétrière
Marie Pia D'orthor, MD principal investigator
Hôpital Bichat - Claude Bernard
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IniVAH and IniVAD in people with Overlap Syndrome, run by IP Santé Domicile at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Géraldine Boy, PhD (0607434961, geraldine.boy@ipsante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance- average adherence measured over the three months under NIV expressed in hours/night (time frame: month 3 (M3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.