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Clinical Trials/NCT03128983
NCT03128983
Completed
Not Applicable

Variations of Physiological Data Throughout the Menstrual Cycle

Ava AG0 sites41 target enrollmentFebruary 1, 2015
ConditionsFertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fertility
Sponsor
Ava AG
Enrollment
41
Primary Endpoint
Correlation between menstrual cycle dynamics and physiology
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.

Registry
clinicaltrials.gov
Start Date
February 1, 2015
End Date
December 31, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ava AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
  • Regular cycling (28 days +/- 2)
  • Non-hormonal contraception methods used
  • German-speaking
  • Written informed consent to participate in the study

Exclusion Criteria

  • Any health-related issues that may affect menstrual cycle
  • Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
  • Frequent travel between time zones
  • Sleeping disorders

Outcomes

Primary Outcomes

Correlation between menstrual cycle dynamics and physiology

Time Frame: During 1 menstrual cycle between 24 days and 35 days

Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics.

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