Insomnia Prevalence and Treatment Impact on Systemic Hypertension

NCT05414864 | Terminated Phase 4 DMC

• 1 other identifier: 5276/21/051
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Insomnia; Hypertension

Keywords

insomnia; hypertension; Ramelteon; sleep hygiene

Outcome Measures

Primary Outcomes (1)

• Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)

  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 Outcomes (4)

• Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)

  3 months

• Efficacy of insomnia treatment on Sleep duration

  3 months

• Efficacy of insomnia treatment on sleep quality

  3 months

• Efficacy of insomnia treatment on subgroups of patients (intending to be a sub-study)

  3 months

Study Arms (2)

Control Group

OTHER

Sleep hygiene alone (control group)

Behavioral: sleep hygiene

Intervention Group

OTHER

Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night

Drug: Ramelteon (RozeremR); Behavioral: sleep hygiene

Interventions

Ramelteon (RozeremR) DRUG

8mg daily

Intervention Group

sleep hygiene BEHAVIORAL

sleep behavioral guidelines

Control Group; Intervention Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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);
• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead
• Takeda: collaborator

Study Sites (1)

Heart Institute (InCor)

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (21)

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  PMID: 15683149 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypertension; Sleep Hygiene

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: team that evaluate the results of complementary exams
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 10, 2022
• Study Start: May 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-07

Locations

BR (1)