NCT05414864

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Insomnia
• Hypertension

Interventions

Type	Name	Description
DRUG	Ramelteon (RozeremR)	8mg daily
BEHAVIORAL	sleep hygiene	sleep behavioral guidelines

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-07-31
• Completion: 2022-09-30
• First posted: 2022-06-10
• Last updated: 2022-12-29

Locations

1 site across 1 country: Brazil