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Completed

NCT Number: NCT05759715

Iris Color and Day-Night Changes in the Sympathovagal Ratio

Iris melanocytes are innervated by parasympathetic and sympathetic nerve endings. Light affects autonomic nervous system activity via the retino-hypothalamic pathway. The hypothesis that the day-to-night variations in the sympatovagal ratio (LF/HF) may differ among individuals with different brown iris patterns was tested.

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Key information

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

A total of 621 healthy adults, aged between 16 and 50, with brown eyes and not diagnosed with a disease that might affect the autonomous nerve system were included in the study. A digital camera was used to acquire iris photos. Subjects were grouped into iris color groups (2-0 bg, 1-0 bg, 1-1 db, 1-1 lb, 2-0 b, and 1-0 b). Iris photos were analyzed with Picture Color Analyzer RBG software. The Central/Peripheral (R/RGB) ratio was used for objective distinction between the groups. Using 24-h Holter ECG monitoring, the change in the sympathovagal ratio from day (between 07:00 and 23:00 hrs) to night (between 23:00 and 07:00 hrs) was determined with the formula [(Day - Night) LF/HF)/Day LF/HF].

Who can participate

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

Inclusion criteria

A total of 650 healthy individuals between the ages of 16 and 50 .

Exclusion criteria

Diseases that could affect the autonomic nervous system; Obesity Obstructive sleep apnea syndrome Hypertension Diabetes mellitus Atrial fibrillation Coronary disease Heart failure Goiter, etc.

Treatment and study plan

Iris Color Measurement , LF/HF Measurement

Other

Iris Color Measurement (Photos were taken of the iris with a digital camera ) LF/ HF Measurement (Using the three-channel standard ambulatory Holter recording system)

Primary outcomes

  1. LF/HF ratio

    Time frame: one week

    low frequency (LF, 0.04-0.15 Hz) and high frequency (HF, 0.16-0.4 Hz) measurements were taken from day and night changes in the heart rate by using the frequency-domain analysis method.

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2023
Registry last updated
Mar 9, 2023

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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