SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP, United Kingdom
NCT Number: NCT04382001
In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.
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Notify Me18 year and older
Female
Observational
Bedford, Bedfordshire, MK44 3UP, United Kingdom
This study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study.
Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitors including heart rate and heart rate variability will be downloaded for comparison.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 month
Heart rate at time points throughout the menstrual cycle
Time frame: 1 month
Heart rate variability at time points throughout the menstrual cycle
Time frame: 1 month
Day of ovulation determined by urinary LH surge +1 day
Time frame: 1 month
Fertile window onset determined by E3G surge
Time frame: 1 month
Fertile window closure determined by P3G rise
Time frame: 1 month
Agreement between wrist band and chest band heart rate data
SPD Development Company Limited
Industry
Further Investigations of Heart Rate Variability During the Menstrual Cycle
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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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