Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)

University of Sao Paulo

Status and phase: Enrolling; Phase 4

Conditions: Hypertension; Insomnia

Treatments: Drug: Eszopiclone 3 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07018557

Investigator initiated Study (Other Identifier)

73710523.3.0000.0068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Placebo + sleep hygiene

Placebo Comparator group

Description:

Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia

Treatment:

Drug: Placebo

Eszopiclone + sleep hygiene

Active Comparator group

Description:

Active treatment for insomnia + sleep counseling

Treatment:

Drug: Eszopiclone 3 mg