Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eszopiclone 3 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Insomnia, Hypertension. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
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:
1. Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index. 2. Evaluation of the Pittsburgh Sleep Quality Index. 3. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale. 4. Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7) 5. Beck form for depression evaluation. 6. Detection of sleep apnea using a portable monitor (BiologixTM) Patients that fulfilled the inclusion criteria will be submitted to a 1-month run-in period before randomization with pill counting for improving medical adherence and defining baseline BP. Then patients with be randomized to sleep hygiene + eszopiclone or sleep hygiene + placebo for 3 months (double-blind study design). We will collect demographic and anthropometric data, as well as concomitant comorbidities, medications, standard BP measurements (office and ABPM) at baseline and after 3 -months.
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.
Interventions
- Drug Eszopiclone 3 mg
Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance). - Drug Placebo
Placebo pills identical to the active comparator.
Primary outcome measures
- Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) [Time frame: 3 months]
Secondary outcome measures (6)
- Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring) [Time frame: 3 months]
- Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring) [Time frame: 3 months]
- Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring) [Time frame: 3 months]
- Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure) [Time frame: 3 months]
- Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index) [Time frame: 3 months]
- Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Adults (30 to 75 years-old)
- 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 >10%);
- Urinuria Incontinence;
- Prostatism;
- History of active cancer;
- Pregnancy;
- Complex sleep behaviors, suicidal behavior.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Academic Research Organization - Heart Institute (InCor) — São Paulo
Identifiers
NCT: NCT07018557 · 73710523.3.0000.0068 · Investigator initiated Study