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Sleep Apnea SyndromePhase 4NCT01796769

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

A Phase 4 study testing Continuous Positive Airway Pressure (CPAP) in sleep apnea patients in people with Sleep Apnea Syndrome and Low Cardiovascular Risk, run by Fédération Française de Pneumologie at 32 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Targeted population: Sleep apnea patients at low cardiovascular risk newly treated by CPAP Hypothesis: Six months CPAP compliance 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 Syndrome, Low Cardiovascular Risk
What is being tested?
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
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 low cardiovascular score (<5% defined by European SCORE)
  • Patient affiliated to the national health insurance
  • Willingness to use a telemonitoring system

Who cannot join

  • Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
  • Central sleep apnea syndrome
  • Previous CPAP treatment with respiratory support for sleep respiratory trouble
  • Cardiac failure
  • Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
  • Terminal disease

Trial locations and contacts

32 sites in 1 country.

Jean Louis PEPIN, Prof, PhD contact

0033476765516 ext. 65516

JPepin@chu-grenoble.fr

32 sites in 1 country

France32 sites, 32 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
  • University Hospital

    Grenoble, 38000

    Jean Louis PEPIN, Prof, PhD

    Patrick LEVY, Prof, PhD

    Recruiting
  • Respiratory physician in private practice

    Grenoble, 38100

    Janie GIREY-RANNAUD, MD

    Recruiting
  • Respiratory physician in private practice

    La Rochelle, 17000

    Frédéric LE GUILLOU, MD

    Claude GENDREAU, MD

    Recruiting
  • University Hospital Calmette

    Lille, 59000

    Anne MALLART-VOISIN, 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

    Recruiting

Other trials in France

About this study

Official title: Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low 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 oximetry, 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 200 patients will be included.

Being tested
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Keywords
Obstructive Sleep Apnea Syndrome, Telemedicine, Patient Compliance
Medical subject headings
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Positive Airway Pressure (CPAP) in sleep apnea patientsDevice

    Usual CPAP treatment in sleep apnea patients

  • Continuous Positive Airway Pressure (CPAP) in sleep apnea patientsDevice

    CPAP treatment with telemedicine system

Study groups in NCT01796769
Study groupRoleWhat they receive
ConventionalExperimentalNot described
Receives: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
TelemedicineActive comparatorNot described
Receives: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline CPAP compliance at 6 months

    CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups.

    Measured: day 0 and month 6

Secondary outcomes (5)
  1. Subjective Sleepiness

    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups

    Measured: inclusion and month 6

  2. Fatigue

    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups

    Measured: inclusion and month 6

  3. 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

  4. Health status

    Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups

    Measured: inclusion and month 6

  5. 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.

  1. First posted22 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796769
Sponsor's protocol ID
11-FFPO-01
Status last verified
Sep 2014
First submitted
15 Feb 2013
Last updated
5 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Continuous Positive Airway Pressure (CPAP) in sleep apnea patients in people with Sleep Apnea Syndrome and Low 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 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 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 ext. 65516, JPepin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline CPAP compliance at 6 months (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.

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