Physiological Data in the Menstrual Cycle

NCT ID: NCT03128983

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland

UNKNOWN

Sponsor Role collaborator

Empa, Swiss Federal Laboratories for Materials Science and Technology

OTHER

Sponsor Role collaborator

Ava AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Emilia

Identifier Type: -

Identifier Source: org_study_id

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