Central Sleep ApneaFACENCT02356367
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)
An observational study of Central Sleep Apnea and Heart Failure, run by ResMed at 3 sites in France.
Trial summary
The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, Heart Failure
- What is being tested?
- telemonitoring
- How many people
- 0 participants
- Where
- 3 sitesFrance
- Study dates
- May 2016to May 2017
- Phase
- Observational
- 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
Study population: Heart Failure patient eligible for adaptative servo-ventilation
Who may be able to join
- Adult Patient with Chronic Heart Failure
- Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy
- Patient is able to fully understand study information and signed informed consent
Who cannot join
- Contra-indications to Adaptative Servo-Ventilation therapy
- Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Henri Mondor
Créteil, 94000
CHU de Grenoble
Grenoble, 38000
CHU Bichat
Paris, 75018
About this study
Official title: French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance
The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.
- Conditions
- Central Sleep Apnea, Heart Failure
- Being tested
- telemonitoring
- Keywords
- telemonitoring, Adaptive servo-ventilation
- Medical subject headings
- Sleep Apnea, Central, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemonitoringOther
Also called Airview
What is being measured
The primary outcome is the main question the study is designed to answer.
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
Autonomic nervous system balance measure by microneurography
Measured: 12 months
Secondary outcomes (6)
anxiety and nervous depression
using Spielberger questionnaire and Beck's Depression Inventory
Measured: 12 months
sleep disordered breathing symptomatology
using Epworth sleepiness scale and Oxford Sleep Resistance Test
Measured: 12 months
Nocturia
evaluated by number of urination per night, diuresis, plasmatic dosage of Atrial Natriuretic peptide, Brain natriuretic peptide, Antidiuretic hormone
Measured: 24 months
sleep quality
evaluated by Pittsburgh Sleep Quality Index; minnesota living with heart failure questionnaire; actimetry; home polysomnography
Measured: 24 months
Heart Failure status
evaluated by echocardiography, New York Heart Association functional classification; Electrocardiography
Measured: 24 months
therapy compliance
evaluated by Morisky Medication Adherence Scale and with telemonitoring data
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356367
- Sponsor's protocol ID
- Face Pilot Study
- Acronym
- FACE
- Status last verified
- Apr 2017
- First submitted
- 2 Feb 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance
- ClinicalTrials.gov ID
- NCT02356367
- Acronym / sponsor ID
- FACE / Face Pilot Study
- Conditions
- Central Sleep Apnea, Heart Failure
- Keywords
- telemonitoring, Adaptive servo-ventilation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 5 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 purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure patient eligible for adaptative servo-ventilation
Key inclusion criteria (3 listed)
- Adult Patient with Chronic Heart Failure
- Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy
- Patient is able to fully understand study information and signed informed consent
Key exclusion criteria (2 listed)
- Contra-indications to Adaptative Servo-Ventilation therapy
- Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy
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 |
|---|---|---|
| telemonitoringAlso: Airview | Other | – |
Primary outcome
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
Time frame: 12 months
Autonomic nervous system balance measure by microneurography
6 secondary outcomes
anxiety and nervous depression
Time frame: 12 months
sleep disordered breathing symptomatology
Time frame: 12 months
Nocturia
Time frame: 24 months
sleep quality
Time frame: 24 months
Heart Failure status
Time frame: 24 months
therapy compliance
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea and Heart Failure, run by ResMed at 3 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography (time frame: 12 months). 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 12 Apr 2017.