InsomniaPhase 4PRYSMA-HTNNCT07018557
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
A Phase 4 study testing Eszopiclone 3 mg in people with Insomnia and Hypertension, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Insomnia, Hypertension
- What is being tested?
- Eszopiclone 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jun 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Academic Research Organization - Heart Institute (InCor)
São Paulo, São Paulo, 05403900
Amanda A Brito, +5511976765005, amanda.abrito@hc.fm.usp.br
About this study
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).
Read the 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:
- Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.
- Evaluation of the Pittsburgh Sleep Quality Index.
- Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
- Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)
- Beck form for depression evaluation.
- 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.
- Conditions
- Insomnia, Hypertension
- Being tested
- Eszopiclone 3 mg, Placebo
- Keywords
- Insomnia, Hypertension, Blood Pressure, Treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eszopiclone 3 mgDrug
Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).
PlaceboDrug
Placebo pills identical to the active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + sleep hygiene | Placebo comparator | Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia Receives: Drug: Placebo |
| Eszopiclone + sleep hygiene | Active comparator | Active treatment for insomnia + sleep counseling Receives: Drug: Eszopiclone 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
To assess the impact of treatment of insomnia with eszopiclone on 24-h blood pressure by ABPM (mmHg).
Measured: 3 months
Secondary outcomes (6)
Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring)
To assess the impact of treatment of insomnia with eszopiclone on daytime and nighttime blood pressure BP (mmHg).
Measured: 3 months
Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring)
To assess the impact of treatment of insomnia with eszopiclone on 24-h, daytime, and nighttime BP control (%).
Measured: 3 months
Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring)
To assess the impact of treatment of insomnia with eszopiclone on non-dipping BP (%).
Measured: 3 months
Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)
To assess the impact of treatment of insomnia with eszopiclone on office BP (mmHg).
Measured: 3 months
Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index)
To assess the impact of treatment of insomnia with eszopiclone on sleep quality (absolute values).
Measured: 3 months
Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index)
To assess the impact of treatment of insomnia with eszopiclone on insomnia severity (absolute values).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start4 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofarma Laboratorios S.A.
- Responsible party
- Principal investigator, Luciano F Drager, MD, PhD, University of Sao Paulo
- Investigators
- Luciano F. Drager, MD, PhD, Study chair, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018557
- Sponsor's protocol ID
- 73710523.3.0000.0068
- Other IDs
- Investigator initiated Study
- Acronym
- PRYSMA-HTN
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
- ClinicalTrials.gov ID
- NCT07018557
- Acronym / sponsor ID
- PRYSMA-HTN / 73710523.3.0000.0068
- Conditions
- Insomnia, Hypertension
- Keywords
- Insomnia, Hypertension, Blood Pressure, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Eurofarma Laboratorios S.A.
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.
- Evaluation of the Pittsburgh Sleep Quality Index.
- Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
- Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)
- Beck form for depression evaluation.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + sleep hygiene | Placebo comparator | Drug: PlaceboPlacebo pill (identical to the active treatment) + sleep counseling for improving insomnia |
| Eszopiclone + sleep hygiene | Active comparator | Drug: Eszopiclone 3 mgActive treatment for insomnia + sleep counseling |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eszopiclone 3 mgEszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance). | Drug | Eszopiclone + sleep hygiene |
| PlaceboPlacebo pills identical to the active comparator. | Drug | Placebo + sleep hygiene |
Primary outcome
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
Time frame: 3 months
To assess the impact of treatment of insomnia with eszopiclone on 24-h blood pressure by ABPM (mmHg).
6 secondary outcomes
Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring)
Time frame: 3 months
Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring)
Time frame: 3 months
Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring)
Time frame: 3 months
Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)
Time frame: 3 months
Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index)
Time frame: 3 months
Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciano F. Drager, MD, PhD study chair
University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone 3 mg in people with Insomnia and Hypertension, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LUCIANO F DRAGER, MD, PhD (+5511988027887, luciano.drager@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.