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

NCT07018557 | Recruiting Phase 4

• 2 other identifiers: 73710523.3.0000.0068Investigator initiated Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; Hypertension

Keywords

Insomnia; Hypertension; Blood Pressure; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring)

  3 months

• Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring)

  3 months

• Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring)

  3 months

• Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)

  3 months

• Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index)

  3 months

Other Outcomes (2)

• Efficacy of insomnia treatment on blood pressure based on the type of insomnia

  3 months

• Efficacy of insomnia treatment on blood pressure according to sleep apnea status

  3 months

Study Arms (2)

Placebo + sleep hygiene

PLACEBO COMPARATOR

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

Drug: Placebo

Eszopiclone + sleep hygiene

ACTIVE COMPARATOR

Active treatment for insomnia + sleep counseling

Drug: Eszopiclone 3 mg

Interventions

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).

Eszopiclone + sleep hygiene

Placebo DRUG

Placebo pills identical to the active comparator.

Placebo + sleep hygiene

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead
• Eurofarma Laboratorios S.A.: collaborator

Study Sites (1)

Academic Research Organization - Heart Institute (InCor)

São Paulo, São Paulo, 05403900, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypertension

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Luciano F. Drager, MD, PhD

  University of Sao Paulo Medical School

  STUDY CHAIR

Central Study Contacts

LUCIANO F DRAGER, MD, PhD

CONTACT

+5511988027887; luciano.drager@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

BR (1)