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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Brazil
Academic Research Organization - Heart Institute (InCor)
RECRUITING
São Paulo
Contact Information
Primary
LUCIANO F DRAGER, MD, PhD
luciano.drager@incor.usp.br
+5511988027887
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Placebo_comparator: Placebo + sleep hygiene
Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia
Active_comparator: Eszopiclone + sleep hygiene
Active treatment for insomnia + sleep counseling
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo
Collaborators: Eurofarma Laboratorios S.A.

This content was sourced from clinicaltrials.gov

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