The study of Ramelteon (RozeremR) at night vs. sleep hygiene for insomnia

University of Sao Paulo is starting a new clinical trial of Insomnia Prevalence and Treatment Impact on Systemic Hypertension.

Insomnia is defined as some difficulty in sleep onset, consolidation, duration, or quality, despite appropriate opportunities for getting sleep. In the last decade, there is growing evidence associating insomnia and high blood pressure, (HBP), coronary disease, heart failure, atrial fibrillation, as well as with an increased mortality rate. Despite the previously mentioned advances, the real impact of insomnia on HBP is unknown. It is unclear whether the diagnosis and pharmacologic treatment of insomnia will have an impact on 24-h BP.

The aim of this first phase is to outline the prevalence of insomnia in patients with HBP followed in the ambulatories from the Hypertension Units at InCor and Hospital das Clínicas. The main hypothesis is that the prevalence of insomnia is high and most patients remain undiagnosed and consequently untreated. For this phase, up to 1,500 patients with HBP will be selected.

The clinical trial started in May 1, 2022 and will continue throughout December 31, 2024.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05414864 or clinicaltrials.gov/ct2/show/NCT05414864.