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New treatment option for Insomnia
Official title Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
ClinicalTrials.gov ID: NCT07018557
What this study is testing
What is Eszopiclone 3 mg?
Eszopiclone 3 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for insomnia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- 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).
You likely can't join if
- 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);
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.