Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 1:25 PM
Study NCT ID:
NCT07018557
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRYSMA-HTN
Brief 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).
Detailed Description:
We will consecutively evaluate the presence of insomnia in adult patients with hypertension under regular treatment recruited from the outpatient clinic at the Heart Institute (InCor).
The following exams will be made:
1. Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.
2. Evaluation of the Pittsburgh Sleep Quality Index.
3. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
4. Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)
5. Beck form for depression evaluation.
6. Detection of sleep apnea using a portable monitor (BiologixTM) Patients that fulfilled the inclusion criteria will be submitted to a 1-month run-in period before randomization with pill counting for improving medical adherence and defining baseline BP. Then patients with be randomized to sleep hygiene + eszopiclone or sleep hygiene + placebo for 3 months (double-blind study design). We will collect demographic and anthropometric data, as well as concomitant comorbidities, medications, standard BP measurements (office and ABPM) at baseline and after 3 -months.
The main hypothesis is that pharmacological treatment, as compared to placebo, will be able to improve insomnia in parallel to a significant decrease in 24-h ABPM (primary outcome). We will also evaluate absolute decrease of daytime and nighttime BP, % of 24-h, daytime, and nighttime BP control, % non-dipping BP, office BP, sleep quality and improvement in insomnia severity index scale as secondary outcomes. Exploratory analysis evaluating the effects of eszopiclone according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). We also explored whether the results will be influenced by the presence of untreated sleep apnea.
The following exams will be made:
1. Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.
2. Evaluation of the Pittsburgh Sleep Quality Index.
3. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
4. Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)
5. Beck form for depression evaluation.
6. Detection of sleep apnea using a portable monitor (BiologixTM) Patients that fulfilled the inclusion criteria will be submitted to a 1-month run-in period before randomization with pill counting for improving medical adherence and defining baseline BP. Then patients with be randomized to sleep hygiene + eszopiclone or sleep hygiene + placebo for 3 months (double-blind study design). We will collect demographic and anthropometric data, as well as concomitant comorbidities, medications, standard BP measurements (office and ABPM) at baseline and after 3 -months.
The main hypothesis is that pharmacological treatment, as compared to placebo, will be able to improve insomnia in parallel to a significant decrease in 24-h ABPM (primary outcome). We will also evaluate absolute decrease of daytime and nighttime BP, % of 24-h, daytime, and nighttime BP control, % non-dipping BP, office BP, sleep quality and improvement in insomnia severity index scale as secondary outcomes. Exploratory analysis evaluating the effects of eszopiclone according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). We also explored whether the results will be influenced by the presence of untreated sleep apnea.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Investigator initiated Study | OTHER | Heart Institute (InCor), University of Sao Paulo Medical School, Brazil | View |