drugset / Trial / NCT05414864

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

NCT05414864

Phase 4 Terminated 5 enrolled University of Sao Paulo Takeda · collab
RandomizedFactorialOpen-labelTreatment

Summary

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 study 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. Besides the medical records with demographic and anthropometric data, personal and familiar background, as well as regular medication, all patients will perform three systematic and standardized blood pressure checks on electric monitors.

Timeline

Start
2022-05-01
Primary completion
2022-07-31
Completion
2022-09-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramelteon Unknown 8 mg