Impact of Telemonitoring to Improve Adherence in Continuous Positive Airway Pressure (CPAP)-Treated Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a
      telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration,
      mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to assess the
      impact of telemonitoring on the delay to the first technical intervention after CPAP
      titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep unit.
      The shortening of this delay could help to improve adherence during the first weeks of
      treatment. As a secondary aim, the investigators would like to assess the impact of
      telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial
      period.
    

Detailed description: 
      Introduction CPAP (continuous positive airway pressure) is the most frequently used and
      effective treatment for obstructive sleep apnea syndrome (OSAS).

      It has been proven to offer a survival benefit in patients with severe disease, to improve
      sleep quality, health-related quality of life and to decrease cardiovascular events, such as
      stroke and myocardial infarction.

      The challenge of this treatment remains to obtain adequate adherence, defined as use during
      at least 4 hours/night and for more than 70% of the nights . Independently of this usually
      accepted cut-off, CPAP effect grows with increased use. A recent randomised study in a cohort
      of 3100 CPAP-treated patients, randomised in intensive versus standard interventions, has
      also confirmed the positive effect of a greater CPAP use (6.9 vs 5.2 h/night) on
      cardiovascular outcomes, indicating that a regular 5-6 hours use/night is required.

      Improvement in adherence can be obtained by supportive, educational and behavioural therapy .
      CPAP specific education is nowadays routinely applied in the center.

      Telemonitoring has also been shown to improve adherence. Other studies have added
      telemonitoring vs. placebo to the usual care in 45 recently diagnosed OSA patients and
      observed a 46% adherence improvement in the telemonitoring group after 2 months.

      In another randomised trial, daily download of CPAP data and consecutive phone-call
      intervention to usual care in 75 OSAS patients. After 3 months, mean adherence was 321 min in
      the telemonitoring arm versus 207 min in the standard arm during the days of use.

      T4P® is a telemonitoring unit added on CPAP device allowing to obtain a daily report of usage
      duration, mask leaks, pressure and apnea-hypopnea index. Data are anonymously transmitted to
      a secured server and analysed on a dedicated web portal.

      The purpose of the present study is to assess the impact of telemonitoring on the delay to
      the first technical intervention after CPAP titration night in CPAP-treated OSAS patients
      managed in the sleep unit. The shortening of this delay could help to improve adherence
      during the first weeks of treatment. As secondary aim, investigators would like to assess the
      impact of telemonitoring on mean adherence during the first 3 months of treatment, which is a
      crucial period.

      Material and methods Consecutive OSAS patients admitted in the sleep unit for CPAP titration
      night will be screened. If patients accept to participate to the study, they will be
      randomised between standard care or telemonitoring CPAP follow-up.

      Standard care After CPAP titration night, patients are instructed to use the device each
      night for the whole night. They receive written instruction and can reach the sleep unit
      (phone call, visit) how often they need, during week days, in order to resolve any
      intercurrent problem interfering with their CPAP use. A group educational session for
      CPAP-treated patients is scheduled 1 month after and a visit to the pneumologist is scheduled
      1.5 months after.

      Telemonitoring follow-up In addition to standard care, the T4P® is added to the CPAP of the
      patient at home. Sleep lab technical staff is instructed to connect to the web portal and to
      analyse patient's data each Tuesdays and Fridays. In case of air leaks, persistant
      significant apnea-hypopnea index, use < 3h on three consecutive days, investigators have to
      call the patient and eventually to ask him to visit the staff of the sleep lab.

      Outcomes

        -  delay between CPAP titration night and first intervention (phone call/visit)

        -  mean CPAP adherence measured during the first 3 months of treatment
    

Intervention name(s): T4PTelemonitoring; CPAP
Intervention type(s): Device; Device
Intervention description(s): addition of a Telemonitoring unit on the CPAP line to standard care.; CPAP treatment for treatment of obstructive sleep apnea syndrome
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; Telemonitoring