Status:
TERMINATED
Insomnia Prevalence and Treatment Impact on Systemic Hypertension
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Takeda
Conditions:
Insomnia
Hypertension
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
Insomnia is defined as some difficulty in sleep onset, consolidation, duration, or quality, despite appropriate opportunities for getting sleep. In the last decade, there is growing evidence associati...
Detailed Description
Prevalence of insomnia in patients with HBP The aim of this study is to outline the prevalence of insomnia in patients with HBP followed by the outpatients' clinics at the InCor and Hospital das Clíni...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 \>8%);
- Urinuria Incontinence;
- Prostatism;
- History of active cancer;
- Pregnancy;
- Complex sleep behaviors, suicidal behavior;
- Other formal labeled contraindications, including a history of angioedema with ramelteone and patients using fluvoxamine (a strong inhibitor of CYP1A2)
Exclusion
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05414864
Start Date
May 1 2022
End Date
September 30 2022
Last Update
December 29 2022
Active Locations (1)
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1
Heart Institute (InCor)
São Paulo, São Paulo, Brazil, 05403-900