Actively Recruiting
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Led by University of Sao Paulo · Updated on 2025-06-12
150
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
E
Eurofarma Laboratorios S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 30 to 75 years
- Body mass index (BMI) less than 40 kg/m2
- Availability to participate in the study
- History of high blood pressure under regular treatment with systolic pressure between 130-160 mmHg and diastolic pressure between 80-100 mmHg
You will not qualify if you...
- Use of benzodiazepines or "Z" drugs
- Night shift workers
- History of severe chronic obstructive pulmonary disease (COPD)
- Heart failure with ejection fraction less than 40% on echocardiogram
- Prior stroke
- Generalized anxiety disorder with GAD-7 score over 14 points and severe depression as per Beck scale
- Severe liver disease
- Alcohol abuse
- Advanced chronic kidney disease stage 4 or 5 with glomerular filtration rate less than 30 ml/min/1.73m2
- Use of loop diuretics
- Type 1 diabetes
- Decompensated type 2 diabetes with glycated hemoglobin over 10%
- Urinary incontinence
- Prostatism
- History of active cancer
- Pregnancy
- Complex sleep behaviors or suicidal behavior
AI-Screening
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Trial Site Locations
Total: 1 location
1
Academic Research Organization - Heart Institute (InCor)
São Paulo, São Paulo, Brazil, 05403900
Actively Recruiting
Research Team
L
LUCIANO F DRAGER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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