Insomnia Prevalence and Treatment Impact on Systemic Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
研究概览
简要总结
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.
详细描述
Prevalence of insomnia in patients with HBP The aim of this study is to outline the prevalence of insomnia in patients with HBP followed by the outpatients' clinics at the 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 recruited. 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. The average of the second and third checks will be the final result.
Furthermore, the following exams will be made:
- Definition of the presence of insomnia following the criteria from DSM V and filling up the insomnia severity index.
- Evaluation of the Pittsburgh Sleep Quality Index.
- Evaluation of obstructive sleep apnea by NoSAS score.
- Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
- Filling the DDAS form for evaluation of perception and impact of insomnia on the life of HBP patients.
- Filling the Beck form for depression evaluation.
The clinical characteristics of HBP patients with and without insomnia will be compared testing the hypothesis that patients with insomnia will be under more blood pressure medications and/or uncontrolled bllod pressure than patients without insomnia. If positive, a multivariate analysis will be performed for adjusting for counfonding factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
team that evaluate the results of complementary exams
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control Group
Sleep hygiene alone (control group)
干预措施: sleep hygiene (Behavioral)
Intervention Group
Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
干预措施: Ramelteon (RozeremR) (Drug)
Intervention Group
Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
干预措施: sleep hygiene (Behavioral)
结局指标
主要结局
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
时间窗: 3 months
To assess the impact of treatment of early insomnia with ramelteon on daytime and nighttime blood presure (in mmHg) in hypertensive patients on 24-hour evaluation of ambulatory blood pressure monitoring.
次要结局
- Efficacy of insomnia treatment on Sleep duration(3 months)
- Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)(3 months)
- Efficacy of insomnia treatment on sleep quality(3 months)
- Efficacy of insomnia treatment on subgroups of patients (intending to be a sub-study)(3 months)
研究者
Luciano F Drager, MD, PhD
Principal Investigator
University of Sao Paulo