Insomnia Prevalence and Treatment Impact on Systemic Hypertension
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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 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. 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.
In this second phase, patients with HBP patients with insomnia will be selected to take part
in the intervention study. One group will receive Ramelteon (RozeremR) at night, on an 8mg
dose plus sleep hygiene, and the second group will do the sleep hygiene alone. The blood
pressure treatment will be kept, with unaltered prescriptions during the time studied. A
randomizing list will be previously crafted for splitting the proposed groups.