| Grant number: | 19/03953-5 |
| Support type: | Research Grants - Research in Public Policies |
| Duration: | September 01, 2019 - August 31, 2021 |
| Field of knowledge: | Health Sciences - Medicine |
| Cooperation agreement: | CNPq - PPSUS |
| Principal Investigator: | Alan Luiz Eckeli |
| Grantee: | Alan Luiz Eckeli |
| Home Institution: | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP (HCMRP). Secretaria da Saúde (São Paulo - Estado). Ribeirão Preto , SP, Brazil |
Abstract
Obstructive Sleep Apnea (OSA) is characterized by recurrent obstruction of the upper airway during sleep, associated with repetitive episodes of decreased oxygen saturation and sympathetic activation. This condition presents a high prevalence, is associated with the increase in the incidence of cerebrovascular disease, cardiac arrhythmias, cognitive impairment, hypertension and death due to several causes. Success for the treatment of OSA is limited by the low rates of compliance to CPAP treatment. The present study aims to develop and implement a program to increase compliance and efficacy in treatment with CPAP for SUS patients with OSA in HC-FMRP-USP. We will carry out a randomized controlled clinical trial, together with the economic evaluation, consisting of a study of cost effectiveness and cost utility, carried out in a single center, with duration of 12 months. The outcomes will be compliance to treatment, quality of life, efficacy, sleepiness, patient satisfaction, and economic analysis. Adult patients with moderate to severe OSA will be recruited. The Intervention group will consist of patients who will receive the following set of actions: standardized and computerized assessment, exposure to informative videos, use of an instant messaging platform, adverse event management protocol, set of masks for adaptation and sleep diary. This group will receive CPAPs with cloud technology and will be monitored daily during the first month of intervention. Subsequently, this analysis will be weekly. During this period, professionals will be able to detect adhesion failures and perform early interventions, such as sending messages with orientations, motivational messages and requesting a return to a new clinical evaluation. The comparison group will consist of patients in regular follow-up. In this follow-up, medical consultations are performed, and the CPAP is provided by SUS. The following tools will be used to carry out this project: Epworth Sleepiness Scale, EQ 5D Quality of Life Scale, Quebec Sleep Scale, Global Clinical Impression Scale, Global Change Perception Scale. The analysis of the proposed outcomes will be determined by a comparative statistical analysis between the intervention group and the comparison group. (AU)