Eszopiclone for lowering blood pressure in adults with insomnia and high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with treated hypertension will be screened for insomnia and undergo baseline questionnaires and portable sleep apnea monitoring. After a one‑month run‑in period to confirm adherence and baseline blood pressure, eligible participants will be randomized in a double‑blind fashion to sleep hygiene plus eszopiclone 3 mg or sleep hygiene plus placebo for three months. The primary outcome is change in 24‑hour ambulatory blood pressure, with secondary outcomes including daytime/nighttime BP changes, non‑dipping status, office BP, and multiple validated sleep and mood scales. Demographic, anthropometric, comorbidity, and medication data will also be collected at baseline and after three months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Academic Research Organization - Heart Institute (InCor)
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: LUCIANO F DRAGER, MD, PhD
• Email: luciano.drager@incor.usp.br
• Phone: +5511988027887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.