Insomnia Prevalence and Treatment Impact on Systemic Hypertension
NCT ID: NCT05414864
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
5 participants
INTERVENTIONAL
2022-05-01
2022-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Control Group
Sleep hygiene alone (control group)
sleep hygiene
sleep behavioral guidelines
Intervention Group
Sleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
Ramelteon (RozeremR)
8mg daily
sleep hygiene
sleep behavioral guidelines
Interventions
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Ramelteon (RozeremR)
8mg daily
sleep hygiene
sleep behavioral guidelines
Eligibility Criteria
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Inclusion Criteria
* Availability to participate
* History of HBP under regular treatment (systolic pressure between 130-160 and diastolic pressure between 80-100 mmHg).
Exclusion Criteria
* 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)
30 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
University of Sao Paulo
OTHER
Responsible Party
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Luciano F Drager, MD, PhD
Principal Investigator
Locations
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Heart Institute (InCor)
São Paulo, São Paulo, Brazil
Countries
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References
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Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
Ford ES, Cunningham TJ, Giles WH, Croft JB. Trends in insomnia and excessive daytime sleepiness among U.S. adults from 2002 to 2012. Sleep Med. 2015 Mar;16(3):372-8. doi: 10.1016/j.sleep.2014.12.008. Epub 2015 Jan 14.
Roth T, Coulouvrat C, Hajak G, Lakoma MD, Sampson NA, Shahly V, Shillington AC, Stephenson JJ, Walsh JK, Kessler RC. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011 Mar 15;69(6):592-600. doi: 10.1016/j.biopsych.2010.10.023. Epub 2010 Dec 31.
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Fernandez-Mendoza J, Vgontzas AN, Liao D, Shaffer ML, Vela-Bueno A, Basta M, Bixler EO. Insomnia with objective short sleep duration and incident hypertension: the Penn State Cohort. Hypertension. 2012 Oct;60(4):929-35. doi: 10.1161/HYPERTENSIONAHA.112.193268. Epub 2012 Aug 14.
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Other Identifiers
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5276/21/051
Identifier Type: -
Identifier Source: org_study_id