Clinical trial NCT02773953: Impact of Telemonitoring to Improve Adherence in Continuous Positive Airway Pressure (CPAP)-Treated Patients
Official title: Impact of Telemonitoring on Delay of Intervention to Improve Precocious Adherence in CPAP-treated Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: CPAP
Telemonitoring
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Patients with obstructive sleep apnea syndrome and AHI \> 20/h, who start treatment with CPAP.

Exclusion Criteria:

* Patients already on treatment with CPAP.
* Patients leaving Belgium for more than 3 weeks during study period.
* Severe restrictive respiratory disorders.
* Severe respiratory or cardiac disease.
* Severe psychiatric disease.

Primary outcomes:
measure: Intervention delay (days)
timeFrame: 3 months
Secondary outcomes:
measure: Adherence to treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU st Pierre-sleep lab
Study officials:
affiliation: CHU St. Pierre, Brussels
name: Marie Bruyneel, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: