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Active Not Recruiting NCT07770958

Circadian Disruption And Cardiovascular Risk In Young Adults With Hypertension

Conditions: Essential Arterial Hypertension, Circadian Disruption

Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Enrollment: 200
Sponsor: Medical University of Sofia

Location: UMHAT " Tcaritca Yanna - ISUL" Sofia Sofia

Summary

This prospective observational study will investigate whether circadian disruption is associated with higher blood pressure and a less favorable cardiovascular profile in young adults aged 18 to 45 years with essential arterial hypertension. Participants will undergo 14 days of wrist actigraphy using the CamNtech MotionWatch 8, 24-hour ambulatory blood pressure monitoring, cardiovascular assessment, laboratory testing, and validated questionnaires assessing perceived stress and insomnia symptoms. Circadian disruption will be classified using a predefined five-component research index based on actigraphy measures. Participants with three or more abnormal circadian indicators will be classified as Circadian Disruption Index-positive and compared with participants with zero to two abnormal indicators. The primary outcome is mean 24-hour systolic blood pressure. Secondary outcomes include nocturnal blood pressure patterns, cardiac structure and function, heart-rate variability, stress, insomnia symptoms, and individual circadian measures. The Circadian Disruption Index is a study-specific research classification and is not intended to diagnose a circadian rhythm sleep-wake disorder.

Eligibility Criteria

Inclusion Criteria: 1. Adults aged 18 to 45 years. 2. Established diagnosis of essential arterial hypertension. 3. Stable antihypertensive treatment for at least 4 weeks before enrollment, when pharmacological treatment is prescribed. 4. Ability and willingness to undergo 14 consecutive days of wrist actigraphy using the CamNtech MotionWatch 8. 5. Ability and willingness to undergo 24-hour ambulatory blood pressure monitoring. 6. Ability to provide written informed consent. Exclusion Criteria: 1. Shift work or night-duty work. 2. Known secondary hypertension. 3. Previously diagnosed circadian rhythm sleep-wake disorder. 4. Known obstructive sleep apnea or other clinically significant sleep-related breathing disorder. 5. Known clinically significant cardiovascular disease other than uncomplicated essential arterial hypertension. 6. Diabetes mellitus. 7. Chronic kidney disease with clinically significant renal impairment. 8. Active thyroid disease or other clinically significant endocrine disorder that may affect blood pressure or circadian rhythm. 9. Current treatment with medications known to substantially alter sleep-wake rhythm or circadian timing. 10. Regular use of hypnotic or sedative medication that could substantially affect actigraphic sleep assessment. 11. Pregnancy. 12. Inability to comply with study procedures or insufficient actigraphy/ABPM recording quality. 13. Any acute illness or unstable medical condition that, in the investigator's opinion, could substantially influence the study outcomes.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07770958). StuddyBuddy aggregates publicly available trial information.