Insomnia Prevalence and Treatment Impact on Systemic Hypertension (Print-HAS)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 150
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- sponsor
- University of Sao Paulo
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 first phase 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.
In this second phase, patients with HBP patients with insomnia will be selected to take part in the intervention study. One group will receive Ramelteon (RozeremR) at night, on an 8mg dose plus sleep hygiene, and the second group will do the sleep hygiene alone. The blood pressure treatment will be kept, with unaltered prescriptions during the time studied. A randomizing list will be previously crafted for splitting the proposed groups.
Description
Phase 1: Prevalence of insomnia in patients with HBP The aim of this first phase 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:
- Definition of the presence of insomnia following the criteria from DSM V and filling up the insomnia severity index.
- Evaluation of the Pittsburgh Sleep Quality Index.
- Evaluation of obstructive sleep apnea by NoSAS score.
- Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
- Filling the DDAS form for evaluation of perception and impact of insomnia on the life of HBP patients.
- 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.
Phase 2: Assessment of the impact of treatment of initial insomnia on blood pressure in hypertensive patients
In this 2nd phase, patients with HBP and initial insomnia selected in the 1st phase will be invited to participate in the intervention study. Some potential candidates not previously enrolled in the first phase can be selected for this one as well.
Selected patients will be allocated to one of two groups:
Sleep hygiene alone (control group) Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
During the execution of the protocol, antihypertensive treatment will be maintained, and changes in the prescriptions of these medications are not allowed during the study period, in order to prevent the effects of adjusting the antihypertensive treatment from interfering with the outcomes. To check adherence, the Morisky-Green 4 scale will be used.
A randomization list will be previously created for allocation to each of the proposed groups. It is important to note that our study will be carried out with the intention-to-treat principle.
Details
| Condition | Insomnia, Hypertension |
|---|---|
| Treatment | Sleep Hygiene, Ramelteon (RozeremR) |
| Clinical Study Identifier | NCT05414864 |
| Sponsor | University of Sao Paulo |
| Last Modified on | 1 July 2022 |
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