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

NCT ID: NCT07018557

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Insomnia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo + sleep hygiene

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pills identical to the active comparator.

Eszopiclone + sleep hygiene

Active treatment for insomnia + sleep counseling

Group Type: ACTIVE_COMPARATOR

Eszopiclone 3 mg

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Placebo

Placebo pills identical to the active comparator.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luciano F Drager, MD, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciano F. Drager, MD, PhD

Role: STUDY_CHAIR

University of Sao Paulo Medical School

Locations

Academic Research Organization - Heart Institute (InCor)

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

LUCIANO F DRAGER, MD, PhD

Role: CONTACT

luciano.drager@incor.usp.br

+5511988027887

Facility Contacts

Amanda A Brito

Role: primary

amanda.abrito@hc.fm.usp.br

+5511976765005

Other Identifiers

Investigator initiated Study

Identifier Type: OTHER

Identifier Source: secondary_id

73710523.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id