Sleep Apnea Syndrome Clinical Trial
Official title:
MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System
The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea Syndrome using an integrated telemedicine platform (MyOSA system)
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper
airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and
daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension ,
cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The
application of a continuous positive airways pressure (CPAP) represents the first line
therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness
and oxygen saturation, reduces cardiovascular risk, ameliorates neurobehavioral performance,
improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP
effectiveness is significantly limited by poor adherence. A closer follow up could improve
CPAP adherence but it would take up more work and additional costs for sleep units.
So, on that account, the investigators propose a study to evaluate the effect of adding a
telemedicine approach to traditional follow up on CPAP treatment compliance, patients'
satisfaction and follow-up costs.
Telemedicine will be provided by an integrated platform composed by a web site
(https://www.myosa.net/menu/login.aspx) and a smartphone application.
Methods:
Design: Prospective randomised clinical study. Follow up: 6 months. Participants: 60 patients
diagnosed as OSA at St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment.
Randomization: Patients will be randomized into two groups differing in CPAP treatment
management (standard care vs. telemedicine). Patients of both groups will be visited in Sleep
Unit at 3st and 6th month after starting CPAP treatment. The CPAP machine of both groups will
be provided with a modem sending daily information about CPAP treatment compliance and
adherence to MyOSA web site (this kind of information will only be actively used during the
follow-up in the telemedicine group).
Intervention:
Group 1- Telemedicine Patients will be fitted with a mask , given a CPAP, and instructed on
how to use the device. An intelligent software specifically developed for this project will
be integrated in the web site. Using patients' baseline data (sociodemographic
characteristics, presence of comorbidities, quality of life, sleepiness, pharmacologic
treatment, toxic habits), the software will be capable to provide an initial prediction of
the expected CPAP compliance at 6 months. Then, the real data about patients' treatment
compliance sent on daily base by the CPAP machine will train the software improving the level
of confidence of the prediction. Based on the prediction of compliance at six months, the
software will provide specific and personalized interventions to modify or maintain this
prediction. Interventions will be administered to the patients through a smartphone
application connected to the web site and specifically developed for this study (MyOSA-App).
Using the mobile-app patients will receive information about their own CPAP compliance and
advice on how to improve compliance. All patients will be visited at 3 and 6 months at sleep
unit. Patients will be checked about progress and adherence to therapy and any problems with
their machine.
Group 2- Standard care Patients will be fitted with a mask and given a CPAP and instructed on
how to use the device. Each CPAP machine will be provided with a modem sending daily
compliance and adherence information to MyOSA web site but no intervention based on these
data is planned in this group. All patients will be visited at 1, 3 and 6 months at sleep
unit. Patients will be checked about progress and adherence to therapy and any problems with
their machine. Information will be downloaded from their machines (CPAP adherence, applied
CPAP pressure, mask leak, and residual respiratory events…).
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