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NCT07770958Active, not recruiting

Circadian Disruption And Cardiovascular Risk In Young Adults With Hypertension

Prospective Observational Study Of Circadian Disruption And Cardiovascular Risk In Young Adults With Arterial Hypertension

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
12 Aug 2026
Start date
1 Sept 2023
Primary completion date
31 Dec 2026
Lead sponsor
Medical University of Sofia
NCT number
NCT07770958

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 1 Sept 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously diagnosed circadian rhythm sleep-wake disorder.
  • Current treatment with medications known to substantially alter sleep-wake rhythm or circadian timing.
  • Regular use of hypnotic or sedative medication that could substantially affect actigraphic sleep assessment.

Other illness

  • Known secondary hypertension.
  • Known obstructive sleep apnea or other clinically significant sleep-related breathing disorder.
  • Known clinically significant cardiovascular disease other than uncomplicated essential arterial hypertension.
  • Diabetes mellitus.
  • Chronic kidney disease with clinically significant renal impairment.
  • Active thyroid disease or other clinically significant endocrine disorder that may affect blood pressure or circadian rhythm.
  • Any acute illness or unstable medical condition that, in the investigator's opinion, could substantially influence the study outcomes.

Other

  • Shift work or night-duty work.
  • Pregnancy.
  • Inability to comply with study procedures or insufficient actigraphy/ABPM recording quality.

Who the study is looking for

  • Adults aged 18 to 45 years.
  • Established diagnosis of essential arterial hypertension.
  • Stable antihypertensive treatment for at least 4 weeks before enrollment, when pharmacological treatment is prescribed.
  • Ability and willingness to undergo 14 consecutive days of wrist actigraphy using the CamNtech MotionWatch 8.
  • Ability and willingness to undergo 24-hour ambulatory blood pressure monitoring.
  • Ability to provide written informed consent.

Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UMHAT " Tcaritca Yanna - ISUL"
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.