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NCT Number: NCT07770958

Circadian Disruption And Cardiovascular Risk In Young Adults With Hypertension

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMHAT " Tcaritca Yanna - ISUL"

Sofia, 1000, Bulgaria

About this study

This study is designed to investigate the relationship between circadian organization, sleep-wake patterns, and cardiovascular characteristics in young adults with established essential arterial hypertension. The study is based on the hypothesis that circadian disruption may be associated with an adverse cardiovascular phenotype, particularly alterations in the 24-hour blood pressure profile and early markers of cardiovascular remodeling.

Circadian organization will be assessed using prolonged ambulatory wrist actigraphy. A predefined research index will integrate five complementary indicators of circadian rhythmicity and sleep-wake regularity. The index is intended to provide an operational and reproducible classification of the degree of circadian disruption within the study population rather than to establish a clinical diagnosis of a circadian rhythm sleep-wake disorder.

Cardiovascular assessment will include ambulatory blood pressure monitoring, echocardiographic assessment of cardiac structure and function, heart-rate variability, and selected metabolic and inflammatory biomarkers. Psychological and sleep-related factors will also be assessed in order to explore the potential contribution of perceived stress and insomnia symptoms to the relationship between circadian organization and cardiovascular characteristics.

The primary analytical approach will compare participants classified as having a positive Circadian Disruption Index with those classified as negative. Multivariable statistical models will subsequently be used to determine whether the observed association between circadian disruption and cardiovascular parameters persists after adjustment for relevant demographic, anthropometric, hypertension-related, treatment-related, and sleep-related factors.

An additional exploratory objective is to evaluate whether a combination of cardiovascular, metabolic, behavioral, and psychological characteristics can identify participants with a higher probability of circadian disruption. This exploratory analysis may contribute to the development of a preliminary cardiovascular-circadian risk metric that could subsequently be evaluated and validated in independent cohorts.

The study is observational and does not assign participants to a therapeutic intervention. The research classification of circadian disruption should not be interpreted as a diagnosis of a circadian rhythm sleep-wake disorder, and the findings will be interpreted in the context of the overall clinical characteristics of the participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Shift work or night-duty work.
  • Known secondary hypertension.
  • Previously diagnosed circadian rhythm sleep-wake disorder.
  • 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.
  • 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.
  • Pregnancy.
  • Inability to comply with study procedures or insufficient actigraphy/ABPM recording quality.
  • Any acute illness or unstable medical condition that, in the investigator's opinion, could substantially influence the study outcomes.

Treatment and study plan

Primary outcomes

  1. Mean 24-Hour Systolic Blood Pressure

    Time frame: During the 14-day actigraphy period

    Mean systolic blood pressure over a valid 24-hour ambulatory blood pressure monitoring period performed during the 14-day actigraphy recording period.

Secondary outcomes

  1. Mean 24-Hour Diastolic Blood Pressure

    Time frame: During the 14-day actigraphy period

    Mean diastolic blood pressure over a valid 24-hour ambulatory blood pressure monitoring period.

  2. Mean Nocturnal Systolic Blood Pressure

    Time frame: During the 14-day actigraphy period

    Mean systolic blood pressure during the predefined nocturnal period measured by 24-hour ambulatory blood pressure monitoring.

  3. Mean Nocturnal Diastolic Blood Pressure

    Time frame: During the 14-day actigraphy period

    Mean diastolic blood pressure during the predefined nocturnal period measured by 24-hour ambulatory blood pressure monitoring.

  4. Nocturnal Systolic Blood Pressure Dipping

    Time frame: During the 14-day actigraphy period

    Percentage reduction in mean nocturnal systolic blood pressure compared with mean daytime systolic blood pressure.

  5. Non-Dipping and Reverse-Dipping Blood Pressure Pattern

    Time frame: During the 14-day actigraphy period

    Proportion of participants demonstrating a non-dipping or reverse-dipping nocturnal systolic blood pressure pattern based on 24-hour ambulatory blood pressure monitoring.

  6. Left Ventricular Mass Index

    Time frame: At baseline assessment

    Left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography.

  7. Left Atrial Volume Index

    Time frame: At baseline assessment

    Left atrial volume indexed to body surface area, assessed by transthoracic echocardiography.

  8. E/e' Ratio

    Time frame: At baseline assessment

    Ratio of early transmitral flow velocity to early diastolic mitral annular velocity as an echocardiographic measure of left ventricular diastolic function.

  9. Global Longitudinal Strain

    Time frame: At baseline assessment

    Left ventricular global longitudinal strain assessed by transthoracic echocardiography.

  10. Heart Rate Variability

    Time frame: During the 14-day actigraphy period

    Heart rate variability assessed using standard time-domain parameters, including SDNN and RMSSD.

  11. Perceived Stress

    Time frame: At baseline assessment

    Perceived psychological stress was assessed using the 10-item Perceived Stress Scale (PSS-10). Each item is rated on a 5-point scale from 0 (never) to 4 (very often), yielding a total score of 0-40. Higher scores indicate greater perceived stress.

  12. Insomnia Severity

    Time frame: At baseline assessment

    Severity of insomnia symptoms was assessed using the Insomnia Severity Index (ISI), a 7-item questionnaire assessing difficulties with sleep onset, sleep maintenance, early morning awakening, satisfaction with sleep, interference with daily functioning, noticeability of sleep problems, and distress caused by sleep difficulties. Each item is scored from 0 to 4, yielding a total score of 0-28, with higher scores indicating greater insomnia severity. Scores of 0-7 indicate no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia.

  13. Interdaily Stability

    Time frame: During the 14-day actigraphy period

    Interdaily Stability (IS) derived from actigraphy to quantify the consistency of the 24-hour activity-rest pattern across monitoring days.

  14. Intradaily Variability

    Time frame: During the 14-day actigraphy period

    Intradaily Variability (IV) derived from actigraphy to quantify fragmentation of the activity-rest rhythm within individual days.

  15. Relative Amplitude

    Time frame: During the 14-day actigraphy period

    Relative Amplitude (RA) derived from actigraphy as a measure of the contrast between the most active and least active periods of the 24-hour cycle.

  16. Sleep-Onset Time Variability

    Time frame: During the 14-day actigraphy period

    Variability in sleep-onset time across the 14-day actigraphy monitoring period, expressed as the standard deviation of sleep-onset time.

  17. Wake-Time Variability

    Time frame: During the 14-day actigraphy period

    Variability in wake time across the 14-day actigraphy monitoring period, expressed as the standard deviation of wake time.

Sponsors and collaborators

Lead sponsor

Medical University of Sofia

Other

Registry information

Official study title

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

Acronym: CIRCA-HT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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