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Physiological Data in the Menstrual Cycle (PDMC)

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Zürich
Centre Suisse d’Electronique et de Microtechnique (CSEM), Switzerland
Eidgenössische Materialprüfungs- und Forschungsanstalt (EMPA), Switzerland
Information provided by (Responsible Party):
Ava AG
ClinicalTrials.gov Identifier:
NCT03128983
First received: April 21, 2017
Last updated: NA
Last verified: April 2017
History: No changes posted
  Purpose
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.

Condition Intervention
Fertility
Device: Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variations of Physiological Data Throughout the Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Ava AG:

Primary Outcome Measures:
  • 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.


Enrollment: 39
Actual Study Start Date: February 1, 2015
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The monitoring of menstrual cycles requires female participants.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Ava AG
ClinicalTrials.gov Identifier: NCT03128983     History of Changes
Other Study ID Numbers: Emilia
Study First Received: April 21, 2017
Last Updated: April 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on April 25, 2017