Insomnia Prevalence and Treatment Impact on Systemic Hypertension (Print-HAS)

University of Sao Paulo

Status and phase: Terminated; Phase 4

Conditions: Hypertension; Insomnia

Treatments: Drug: Ramelteon (RozeremR); Behavioral: sleep hygiene

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05414864

5276/21/051

Details and patient eligibility

About

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 associating insomnia and high blood pressure, (HBP), coronary disease, heart failure, atrial fibrillation, as well as with an increased mortality rate. Despite the previously mentioned advances, the real impact of insomnia on HBP is unknown. It is unclear whether the diagnosis and pharmacologic treatment of insomnia will have an impact on 24-h BP. The aim of this study is to outline the prevalence of insomnia in patients with HBP followed in the ambulatories from the Hypertension Units at InCor and Hospital das Clínicas. The main hypothesis is that the prevalence of insomnia is high and most patients remain undiagnosed and consequently untreated. For this phase, up to 1,500 patients with HBP will be selected. Besides the medical records with demographic and anthropometric data, personal and familiar background, as well as regular medication, all patients will perform three systematic and standardized blood pressure checks on electric monitors.

Full 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 Clínicas. The main hypothesis is that the prevalence of insomnia is high and most patients remain undiagnosed and consequently untreated. For this phase, up to 1,500 patients with HBP will be recruited. Besides the medical records with demographic and anthropometric data, personal and familiar background, as well as regular medication, all patients will perform three systematic and standardized blood pressure checks on electric monitors. The average of the second and third checks will be the final result.

Furthermore, the following exams will be made:

1. Definition of the presence of insomnia following the criteria from DSM V and filling up the insomnia severity index.
2. Evaluation of the Pittsburgh Sleep Quality Index.
3. Evaluation of obstructive sleep apnea by NoSAS score.
4. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
5. Filling the DDAS form for evaluation of perception and impact of insomnia on the life of HBP patients.
6. Filling the Beck form for depression evaluation.

The clinical characteristics of HBP patients with and without insomnia will be compared testing the hypothesis that patients with insomnia will be under more blood pressure medications and/or uncontrolled bllod pressure than patients without insomnia. If positive, a multivariate analysis will be performed for adjusting for counfonding factors.

Enrollment: 5 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Control Group

Other group

Description:

Sleep hygiene alone (control group)

Treatment:

Behavioral: sleep hygiene

Intervention Group

Other group

Description:

Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night

Treatment:

Behavioral: sleep hygiene

Drug: Ramelteon (RozeremR)