Insomnia Prevalence and Treatment Impact on Systemic Hypertension

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Takeda

Criteria

Inclusion criteria:

• BMI <40Kg/m2;

• Availability to participate

• History of HBP under regular treatment (systolic pressure between 130-160 and diastolic pressure between 80-100 mmHg).

Exclusion criteria:

• Use of benzodiazepines or "Z" drugs;

• Night workers;

• History of severe chronic obstructive pulmonary disease (COPD);

• Heart failure (ejection fraction <40% on echocardiogram);

• Prior stroke;

• Generalized anxiety disorder (GAD-7 >14 points) and severe depression (Beck);

• Severe liver disease;

• Alcohol abuse;

• Advanced chronic kidney disease 4 or 5 (glomerular filtration rate <30ml/min/1.73m2);

• Patient who is on loop diuretics;

• Patient with type 1 diabetes;

• Patient with decompensated type 2 diabetes (Glycated hemoglobin >8%);

• Urinuria Incontinence;

• Prostatism;

• History of active cancer;

• Pregnancy;

• Complex sleep behaviors, suicidal behavior;

• Other formal labeled contraindications, including a history of angioedema with ramelteone and patients using fluvoxamine (a strong inhibitor of CYP1A2)