Sleep Apnea SyndromesPhase 4NCT01505959
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
A Phase 4 study testing CPAP treatment in people with Sleep Apnea Syndromes and High Cardiovascular Risk, run by Fédération Française de Pneumologie at 32 sites in France.
Trial summary
Targeted population: Sleep apnea patients at high cardiovascular risk newly treated by CPAP Hypothesis: Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Sleep Apnea Syndromes, High Cardiovascular Risk
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 32 sitesFrance
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 4
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 78 years
- Men and women
- AHI > 30 / hour
- Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- Patient affiliated to the National health insurance
- Willingness to use a telemonitoring system
Who cannot join
- Central sleep apnea syndrome
- Previous CPAP treatment with respiratory support for sleep respiratory trouble
- Cardiac failure with left ventricular ejection fraction lesser than 40%
- Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
- Terminal disease
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites, 32 recruiting
- Recruiting
Respiratory physician in private practice
Albertville, 73200
Dominique LIGEONNET, MD
- Recruiting
Respiratory physician in private practice
Annecy, 74000
François BON, MD
- Recruiting
Respiratory physician in private practice
Bordeaux, 33000
Marc SAPENE, MD
François PELLET, MD
- Recruiting
General Hospital
Cannes, 06401
Christophe PERRIN, MD
- Recruiting
General Hospital
Denain, 59225
Jean-Pierre GRIGNET, MD
- Recruiting
Dieulefit Santé Clinic
Dieulefit, 26220
Frédéric HERENGT, MD
- Recruiting
Respiratory physician in private practice
Échirolles, 38130
François ARBIB, MD
Nathalie CHOURI, MD
- Recruiting
Saint Vincent Clinic
Épernay, 51200
Eric BONGRAIN, MD
- Recruiting
Respiratory physician in private practice
Grenoble, 38000
Janie GIREY-RANNAUD, MD
- Recruiting
University Hospital
Grenoble, 38000
Jean-Louis PEPIN, Prof, PhD
Patrick LEVY, Prof, PhD
- Recruiting
Respiratory physician in private practice
La Rochelle, 17000
Frédéric LE GUILLOU, MD
Claude GENDREAU, MD
- Recruiting
University Hospital Calmette
Lille, 59000
Anne MALLART, MD
Stéphanie FRY, MD
- Recruiting
La Louvière Clinic
Lille, 59800
Thibaut GENTINA, MD
Jean Marc DERNIS, MD
- Recruiting
General Hospital
Magny-en-Vexin, 95420
Sylvie NARES, MD
- Recruiting
Ambroise Paré Hospital
Marseille, 13000
Hervé PEGLIASCO, MD
- Recruiting
General Hospital
Montélimar, 26216
Dominique MARTINEAU, MD
Gilbert SALARD, MD
- Recruiting
Respiratory physician in private practice
Montigny-lès-Metz, 57950
Dominique MULLER, MD
- Recruiting
Respiratory physician in private practice
Nîmes, 30900
Olivier BENEZET, MD
- Recruiting
Les Rieux Clinic
Nyons, 26110
Gabrielle VOTTERO, MD
Jorge Lucilo BENGOLEA, MD
- Recruiting
Hospital Bichat Claude Bernard
Paris, 75018
Marie-Pia D'ORTHO, Prof, PhD
- Recruiting
Respiratory physician in private practice
Reims, 51000
Frédéric MASURE, MD
- Recruiting
University Hospital
Rouen, 76000
Jean-François MUIR, Prof, PhD
- Recruiting
General Hospital
Saint-Avold, 57500
Christian KOLTES, MD
- Recruiting
Respiratory physician in private practice
Saint-Etienne, 42100
Dominique MOUNIER, MD
- Recruiting
Respiratory physician in private practice
Saint-Ismier, 38330
Dominique BERTRAND, MD
- Recruiting
Respiratory physician in private practice
Saint-Laurent-du-Var, 06700
Guy BOYER, MD
- Recruiting
Respiratory physician in private practice
Saint-Omer, 62500
Philippe RICHARD, MD
- Recruiting
Respiratory physician in private practice
Six-Fours-les-Plages, 83140
Mireille PADOVANI, MD
Gaël CHAIGNEAU, MD
- Recruiting
Respiratory physician in private practice
Toulon, 83000
Mathieu LARROUSSE, MD
Catherine PACCHIONI, MD
- Recruiting
Respiratory physician in private practice
Valence, 26000
Yves GRILLET, MD
Florence BOIS, MD
- Recruiting
Tessier Clinic
Valenciennes, 59300
Bruno STACH, MD
- Recruiting
Hospital Nord Ouest
Villefranche-sur-Saône, 69655
Lionel FALCHERO, MD
About this study
Official title: Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform
Targeted population:
Sleep apnea patients at high cardiovascular risk newly treated by CPAP
Hypothesis:
Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
Read the detailed description
Study procedures:
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 300 patients will be included.
- Conditions
- Sleep Apnea Syndromes, High Cardiovascular Risk
- Being tested
- CPAP treatment
- Keywords
- Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
Usual CPAP treatment
CPAP treatmentDevice
CPAP treatment with telemedicine system
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Experimental | Not described Receives: Device: CPAP treatment |
| Telemedicine | Active comparator | Not described Receives: Device: CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure evolution by comparing baseline and 6 months measurements
Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)
Measured: day 0 and month 6
Secondary outcomes (8)
Objective CPAP compliance at 6 months
CPAP compliance assessed after 6 months in the two groups
Measured: day 0 and month 6
Diastolic blood pressure evolution by comparing baseline and 6 months
Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
Measured: day 0 and month 6
Subjective Sleepiness
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
Measured: inclusion and month 6
Fatigue
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
Measured: inclusion and month 6
Quality of Life
Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups
Measured: inclusion and month 6
Health status
Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
Measured: inclusion and month 6
Physical activity
Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
Measured: inclusion and month 6
Cost analysis
Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startFeb 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fédération Française de Pneumologie
- Sponsor type
- University, hospital or other
- Collaborators
- Federation of Medical Specialties
- Responsible party
- Principal investigator, Jean Louis PEPIN, Fédération Française de Pneumologie
- Investigators
- Jean Louis PEPIN, Prof, PhD, Principal investigator, University Hospital, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505959
- Sponsor's protocol ID
- 11-FFPO-02
- Status last verified
- Sep 2014
- First submitted
- 5 Jan 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform
- ClinicalTrials.gov ID
- NCT01505959
- Acronym / sponsor ID
- 11-FFPO-02
- Conditions
- Sleep Apnea Syndromes, High Cardiovascular Risk
- Keywords
- Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 936 participants (estimated)
- Lead sponsor
- Fédération Française de PneumologieUniversity, hospital or other
- Collaborators
- Federation of Medical Specialties
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Jan 2012 (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.
Targeted population:
Sleep apnea patients at high cardiovascular risk newly treated by CPAP
Hypothesis:
Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
Detailed description
Study procedures:
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 300 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Experimental | Device: CPAP treatment |
| Telemedicine | Active comparator | Device: CPAP treatment |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 to 78 years
- Men and women
- AHI > 30 / hour
- Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- Patient affiliated to the National health insurance
Key exclusion criteria (5 listed)
- Central sleep apnea syndrome
- Previous CPAP treatment with respiratory support for sleep respiratory trouble
- Cardiac failure with left ventricular ejection fraction lesser than 40%
- Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
- Terminal disease
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 |
|---|---|---|
| CPAP treatmentUsual CPAP treatment | Device | Conventional |
| CPAP treatmentCPAP treatment with telemedicine system | Device | Telemedicine |
Primary outcome
Systolic blood pressure evolution by comparing baseline and 6 months measurements
Time frame: day 0 and month 6
Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)
8 secondary outcomes
Objective CPAP compliance at 6 months
Time frame: day 0 and month 6
Diastolic blood pressure evolution by comparing baseline and 6 months
Time frame: day 0 and month 6
Subjective Sleepiness
Time frame: inclusion and month 6
Fatigue
Time frame: inclusion and month 6
Quality of Life
Time frame: inclusion and month 6
Health status
Time frame: inclusion and month 6
Physical activity
Time frame: inclusion and month 6
Cost analysis
Time frame: month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
Related trials for Sleep Apnea Syndromes
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
Jean Louis PEPIN, Prof, PhD principal investigator
University Hospital, Grenoble, France
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP treatment in people with Sleep Apnea Syndromes and High Cardiovascular Risk, run by Fédération Française de Pneumologie at 32 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 5 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jean Louis PEPIN, Prof, PhD (0033476765516, JPepin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure evolution by comparing baseline and 6 months measurements (time frame: day 0 and month 6). 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 5 Sep 2014.