RecruitingPhase 4NCT07018557

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

Sponsor

University of Sao Paulo

Enrollment

150 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia Hypertension

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).

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sleep medication called eszopiclone (a non-benzodiazepine sleep aid) can help lower blood pressure in people who have both trouble sleeping and high blood pressure that is already being treated. **You may be eligible if...** - You are between 30 and 75 years old - Your BMI is under 40 - You have high blood pressure that is being treated with medication (systolic between 130–160, diastolic 80–100) **You may NOT be eligible if...** - You currently take benzodiazepines or "Z" sleep drugs (like zolpidem) - You work night shifts - You have severe COPD, heart failure, or have had a stroke - You have severe anxiety or severe depression - You have severe liver disease or advanced chronic kidney disease - You take loop diuretics (like furosemide) - You have type 1 diabetes or poorly controlled type 2 diabetes - You have urinary incontinence, prostate problems, or active cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEszopiclone 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).

DRUGPlacebo

Placebo pills identical to the active comparator.

Locations(1)

Academic Research Organization - Heart Institute (InCor)

São Paulo, São Paulo, Brazil

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NCT07018557

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