A Phase 4 interventional study of Ramelteon (RozeremR) and sleep hygiene in Insomnia and Hypertension, sponsored by University of Sao Paulo. Terminated at 1 site in Brazil. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
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.
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:
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 5 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion criteria:
Sleep hygiene alone (control group)
Behavioral: sleep hygiene
Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
Drug: Ramelteon (RozeremR) · Behavioral: sleep hygiene
8mg daily
sleep behavioral guidelines
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
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.
Time frame: 3 months
Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)
To evaluate the impact of treating initial insomnia with ramelteone on office blood pressure in hypertensive patients on office blood pressure (in mmHg)
Time frame: 3 months
Efficacy of insomnia treatment on Sleep duration
To assess the impact of treating insomnia with ramelteon in hypertensive patients on sleep duration evaluated by actigraphy (and reported in minutes of sleep);
Time frame: 3 months
Efficacy of insomnia treatment on sleep quality
To evaluate the impact of treating insomnia with ramelteon in hypertensive patients on sleep quality;
Time frame: 3 months
Efficacy of insomnia treatment on subgroups of patients (intending to be a sub-study)
Assess whether the pressure response of insomnia treatment on the primary and secondary outcomes is mediated by the presence of obstructive sleep apnea.
Time frame: 3 months
Ran from May 2022 to primary completion in Jul 2022, 2 months.
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Studies of the drug tested here: Ramelteon
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