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| ID | Type | Description | Link |
|---|---|---|---|
| Investigator initiated Study | Other Identifier | Heart Institute (InCor), University of Sao Paulo Medical School, Brazil |
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| Name | Class |
|---|---|
| Eurofarma Laboratorios S.A. | INDUSTRY |
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Insomnia is a common sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite appropriate opportunities for getting sleep. Growing evidence has associated insomnia with prevalent and incidence of hypertension. However, the impact of the pharmacologic treatment of insomnia on office blood pressure (BP) and 24-h ambulatory BP monitoring (ABPM) in unclear. Therefore, the aim of this study is to evaluate the impact of eszopiclone, a non-benzodiazepine hypnotic that binds to certain subunits of the gamma-aminobutyric acid type A receptors GABA-A (such as α1, α3, and α5) promoting relaxation and sleep. Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).
We will consecutively evaluate the presence of insomnia in adult patients with hypertension under regular treatment recruited from the outpatient clinic at the Heart Institute (InCor).
The following exams will be made:
The main hypothesis is that pharmacological treatment, as compared to placebo, will be able to improve insomnia in parallel to a significant decrease in 24-h ABPM (primary outcome). We will also evaluate absolute decrease of daytime and nighttime BP, % of 24-h, daytime, and nighttime BP control, % non-dipping BP, office BP, sleep quality and improvement in insomnia severity index scale as secondary outcomes. Exploratory analysis evaluating the effects of eszopiclone according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). We also explored whether the results will be influenced by the presence of untreated sleep apnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + sleep hygiene | Placebo Comparator | Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia |
|
| Eszopiclone + sleep hygiene | Active Comparator | Active treatment for insomnia + sleep counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone 3 mg | Drug | Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) | To assess the impact of treatment of insomnia with eszopiclone on 24-h blood pressure by ABPM (mmHg). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring) | To assess the impact of treatment of insomnia with eszopiclone on daytime and nighttime blood pressure BP (mmHg). | 3 months |
| Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of insomnia treatment on blood pressure based on the type of insomnia | To assess the impact of treatment of insomnia with eszopiclone on blood pressure according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). | 3 months |
| Efficacy of insomnia treatment on blood pressure according to sleep apnea status |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUCIANO F DRAGER, MD, PhD | Contact | +5511988027887 | luciano.drager@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Luciano F. Drager, MD, PhD | University of Sao Paulo Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Research Organization - Heart Institute (InCor) | Recruiting | São Paulo | São Paulo | 05403900 | Brazil |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Placebo | Drug | Placebo pills identical to the active comparator. |
|
To assess the impact of treatment of insomnia with eszopiclone on 24-h, daytime, and nighttime BP control (%). |
| 3 months |
| Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring) | To assess the impact of treatment of insomnia with eszopiclone on non-dipping BP (%). | 3 months |
| Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure) | To assess the impact of treatment of insomnia with eszopiclone on office BP (mmHg). | 3 months |
| Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index) | To assess the impact of treatment of insomnia with eszopiclone on sleep quality (absolute values). | 3 months |
| Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index) | To assess the impact of treatment of insomnia with eszopiclone on insomnia severity (absolute values). | 3 months |
To assess the impact of treatment of insomnia with eszopiclone on blood pressure in patients with and without sleep apnea. |
| 3 months |
| D001523 |
| Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011725 |
| Pyridines |