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

December 27, 2022 updated by: Luciano F Drager, MD, PhD, University of Sao Paulo
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-900
        • Heart Institute (InCor)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Sleep hygiene alone (control group)
Behavioral: sleep hygiene
sleep behavioral guidelines
Other: Intervention Group
Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
Behavioral: sleep hygiene
sleep behavioral guidelines
Drug: Ramelteon (RozeremR)
8mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)
Time Frame: 3 months
To assess the impact of treatment of early insomnia with ramelteon on daytime and nighttime blood presure (in mmHg) in hypertensive patients on 24-hour evaluation of ambulatory blood pressure monitoring.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)
Time Frame: 3 months
To evaluate the impact of treating initial insomnia with ramelteone on office blood pressure in hypertensive patients on office blood pressure (in mmHg)
3 months
Efficacy of insomnia treatment on Sleep duration
Time Frame: 3 months
To assess the impact of treating insomnia with ramelteon in hypertensive patients on sleep duration evaluated by actigraphy (and reported in minutes of sleep);
3 months
Efficacy of insomnia treatment on sleep quality
Time Frame: 3 months
To evaluate the impact of treating insomnia with ramelteon in hypertensive patients on sleep quality;
3 months
Efficacy of insomnia treatment on subgroups of patients (intending to be a sub-study)
Time Frame: 3 months
Assess whether the pressure response of insomnia treatment on the primary and secondary outcomes is mediated by the presence of obstructive sleep apnea.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5276/21/051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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