Continuous positive airway pressure (CPAP) is worldwide considered as the standard treatment of sleep apnea/hypopnea syndrome (SAHS) although studies on the effectiveness of this treatment are limited. The aim of our study was to evaluate the effectiveness of CPAP in improving SAHS-related symptoms, daytime function, perceived health status, and quality of life in patients with moderate to severe SAHS. The effect of conservative treatment (CT) measures-sleep hygiene and weight loss- was compared with CT + CPAP. We included 105 consecutive patients (13 females, age 53 +/- 10 yr, body mass index [BMI] = 32 +/- 6 kg/m2, apnea/hypopnea index [AHI] = 56 +/- 20, Epworth sleepiness scale [ESS] = 12 +/- 5) who met our criteria for CPAP treatment. Patients were randomly allocated in two groups of similar characteristics. Group 1 (n = 37) was asked to improve sleep hygiene and started a weight loss program. Group 2 (n = 68) received, in addition, treatment with CPAP. Both groups were followed through weekly telephone calls and appointments. Sleepiness, other symptoms related to SAHS, daytime function, perceived health status, and quality of life were assessed through questionnaires at inclusion and after 3 mo of treatment. The relief of sleepiness and other SAHS-related clinical symptoms and improvement in perceived health status was much greater in Group 2 receiving CT + CPAP compared with Group 1, only receiving CT. The odds of experiencing a treatment response with CPAP + CT compared with CT alone was 6.52 (odds ratio [OR] = 2.51 to 17.6, 95% confidence interval [95% CI]). CPAP is currently the treatment of choice. At this time, the indication of CPAP treatment in moderate to severe SAHS is adequately supported.