Neuromuscular DiseasesTele-VADNCT02103790
Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
A study testing Home NIV installation in people with Neuromuscular Diseases and Kyphoscoliosis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases, Kyphoscoliosis, Non Invasive Ventilation
- What is being tested?
- Home NIV installation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or Women aged over 18 years
- Neuromuscular disease or kyphoscoliosis
- At least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia
- At least one sign among : hypercapnia > 45 mmHg, desaturation time < 88%, night desaturation time > 5 min, Vital Capacity < 60% or Pimax < 60 cm H2O.
Who cannot join
- Mechanic ventilation refusal
- Patient living alone
- Acute respiratory failure
- Patient who need a third party for the ventilation installation
- Severe respiratory limitation
- Home oxygen
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Raymond Poincaré
Garches, 92380
David ORLIKOWSKI, Ph.D MD, 33(0) 147107777, david.orlikowski@rpc.aphp.fr
Adam OGNA, MD
About this study
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.
For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.
The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.
Read the detailed description
For the study protocol, patients will be hospitalized for the first day to define the ventilation mode and initial parameters, and to choose the best adapted interface.
Then, the patient is discharged from hospital and parameters adaptation is continued at home during the following five days by the hospital medical staff, using telemedicine. An ASV Santé employee visits the patient at home everyday during 5 days to ensure follow-up.
- Being tested
- Home NIV installation
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home NIV installationDevice
| Study group | Role | What they receive |
|---|---|---|
| Home NIV installation | Experimental | Not described Receives: Device: Home NIV installation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of required days to obtain a 4-hours-night ventilation
Measured: 5 days
Secondary outcomes (12)
Number of ventilation hours per 24 hours during the 5 first days
Measured: 5 days
Capno-oximetry improvement at D5
Measured: 5 days
Capno-oximetry and arterial blood gases improvement at D30
Measured: 30 days
Clinical signs decrease (symptoms, dyspnea, drowsiness)
Measured: 30 days
Number of non programmed home visits
Measured: 5 days
Economic cost evaluation
Measured: 5 days
Number of skin slough caused by interface position
Measured: 30 days
Number of hospitalization for respiratory or ventilation disorder
Measured: 30 days
Satisfaction scale for the patient and his family at D5 and D30
CSQ8 and VAS (Visual Analogical Scale)
Measured: 30 days
Quality of life (SF36) at D1 and D30
Measured: 30 days
Reliability of telemonitoring
Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
Measured: 5 days
Reliability of telemedicine
Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, david orlikowski, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103790
- Sponsor's protocol ID
- 2013-A01817-38
- Acronym
- Tele-VAD
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
- ClinicalTrials.gov ID
- NCT02103790
- Acronym / sponsor ID
- Tele-VAD / 2013-A01817-38
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Apr 2014 (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.
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.
For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.
The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.
Detailed description
For the study protocol, patients will be hospitalized for the first day to define the ventilation mode and initial parameters, and to choose the best adapted interface.
Then, the patient is discharged from hospital and parameters adaptation is continued at home during the following five days by the hospital medical staff, using telemedicine. An ASV Santé employee visits the patient at home everyday during 5 days to ensure follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home NIV installation | Experimental | Device: Home NIV installation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or Women aged over 18 years
- Neuromuscular disease or kyphoscoliosis
- At least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia
- At least one sign among : hypercapnia > 45 mmHg, desaturation time < 88%, night desaturation time > 5 min, Vital Capacity < 60% or Pimax < 60 cm H2O.
Key exclusion criteria (6 listed)
- Mechanic ventilation refusal
- Patient living alone
- Acute respiratory failure
- Patient who need a third party for the ventilation installation
- Severe respiratory limitation
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 |
|---|---|---|
| Home NIV installation | Device | Home NIV installation |
Primary outcome
Number of required days to obtain a 4-hours-night ventilation
Time frame: 5 days
12 secondary outcomes
Number of ventilation hours per 24 hours during the 5 first days
Time frame: 5 days
Capno-oximetry improvement at D5
Time frame: 5 days
Capno-oximetry and arterial blood gases improvement at D30
Time frame: 30 days
Clinical signs decrease (symptoms, dyspnea, drowsiness)
Time frame: 30 days
Number of non programmed home visits
Time frame: 5 days
Economic cost evaluation
Time frame: 5 days
Number of skin slough caused by interface position
Time frame: 30 days
Number of hospitalization for respiratory or ventilation disorder
Time frame: 30 days
Satisfaction scale for the patient and his family at D5 and D30
Time frame: 30 days
Quality of life (SF36) at D1 and D30
Time frame: 30 days
Reliability of telemonitoring
Time frame: 5 days
Reliability of telemedicine
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home NIV installation in people with Neuromuscular Diseases and Kyphoscoliosis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 4 inclusion and 6 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 David ORLIKOWSKI, MD Ph.D (01 47 10 77 77, david.orlikowski@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of required days to obtain a 4-hours-night ventilation (time frame: 5 days). 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 9 Mar 2017.