Abstract
Introduction: A previous study showed that sleep deprived people were perceived as less healthy, less attractive, and more tired than after a normal night's sleep (Axelsson et al., Beauty sleep: experimental study on the perceived health and attractiveness of sleep deprived people. BMJ 2010;341:c6614). We believe that likewise sleep deprivation, patients with OSA also are perceived as less attractive, tired, healthy and look older than your age. We therefore hypothesized that the treatment of OSA with continuous positive airway pressure (CPAP) will positively affect the appearance of the patient. The purpose of this study is to compare effects of one month of treatment of CPAP and placebo on appearance of patient with OSA in a prospective, randomized, and crossover study. Methods: We will include 30 consecutive patients of both genders, aged between 30 and 60 years, referred to the sleep clinic of the Heart Institute (InCor) of University of Sao Paulo, with a history of snoring, excessive sleepiness, and with severe OSA confirmed by polysomnography. Patients will be excluded if presenting previous treatment for sleep-disordered breathing, previous diagnosis of chronic diseases that interfere with sleep patterns and history the chronic use of alcohol, sedatives or drugs of abuse, in the last month. Included patients will be randomized into two treatment groups: 1) Placebo arm - use of nasal dilator strip; and 2) CPAP arm - use of CPAP. At the first night of each treatment the patients will be submitted to a polysomnography with nasal strip (placebo arm) or to CPAP titration (CPAP arm). After one month of treatment in the first randomized arm, patients will be submitted to one week without treatment (washout period). After washout period, patients will be assigned to the treatment crossover, i.e., patients in group 1) will receive CPAP therapy and patients in Group 2) will receive placebo treatment, during a period of one additional month. Excessive sleepiness (Epworth Sleepiness Scale) and quality of life (Functional Outcomes of Sleep Questionnaire - FOSQ-10) will be evaluated in the three experimental times: baseline (immediately before treatment), one month (after one month of treatment defined at baseline), and 2 months (after one month of treatment crossover). During the study period, the patients will be followed by trained professionals and will receive all the necessary information about the use of each treatment. After three days of treatment, patients will be contacted by phone to ensure the adherence treatment and to solve potential doubts. After each week of treatment, patients should return to the sleep clinic to management of the adherence data from the memory card and to have reinforced the information about the study protocol. Any issues or concerns about the treatment will be also solved by phone calls. The main outcome of the study will be the evaluations of photographs by 100 independent observers. All patients will be photographed in the three experimental times: baseline (immediately before treatment), one month (after one month of treatment defined at baseline) and 2 months (after one month of treatment crossover). Photographs will be taken by a trained photographer in a standardized manner. The photographer will be blind to the experimental condition of patients. The photographs will be displayed at a fixed interval of six seconds in a randomized order for 100 observers (general population, both genders, similar socio-economic status and education), who will be unaware of the conditions of the study. The observers will rate the faces for attractiveness (very unattractive to very attractive), health (very sick to very healthy), and tiredness (not at all tired to very tired) on a 100 mm visual analogue scale. Age perceived will be rated by the observers' evaluation. (AU)
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