NCT07018557RecruitingPhase 4
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- High blood pressure
- NCT number
- NCT07018557
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 4 Jun 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of benzodiazepines or "Z" drugs;
- Prior stroke;
Other illness
- History of severe chronic obstructive pulmonary disease (COPD);
- Generalized anxiety disorder (GAD-7 \>14 points) and severe depression (Beck);
- Severe liver disease;
- Advanced chronic kidney disease 4 or 5 (glomerular filtration rate \<30ml/min/1.73m2);
- Patient with type 1 diabetes;
- History of active cancer;
Lab values
- Heart failure (ejection fraction \<40% on echocardiogram);
- Patient with decompensated type 2 diabetes (Glycated hemoglobin \>10%);
Other
- Night workers;
- Alcohol abuse;
- Patient who is on loop diuretics;
- Urinuria Incontinence;
- Prostatism;
- Pregnancy;
- Complex sleep behaviors, suicidal behavior.
Who the study is looking for
- 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).
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Research Organization - Heart Institute (InCor) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.