Wearable device to track perimenopausal and menopausal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study asks perimenopausal women to wear IdentifyHer’s non-invasive wearable sensor and complete a daily electronic diary plus questionnaires on stress, anxiety, and sleep. The device’s algorithm-generated events will be compared to participant self-reports in the app to measure agreement and accuracy. Outcomes will include metrics such as sensitivity, specificity, and overall concordance for vasomotor symptoms, sleep disturbances, and anxiety-related patterns. The study is run with KGK Science Inc. in London, Ontario and enrolls generally healthy women who report hot flashes or night sweats.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Females between 35-55 years of age, inclusive
2. Self-reported perimenopausal women experiencing hot flushes or night sweats
3. Individuals of child-bearing potential must confirm they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:

   * Double-barrier method
   * Intrauterine devices
   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   * Vasectomy of partner at least 6 months prior to screening
   * Abstinence
4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
5. Provided voluntary and informed consent to participate in the study
6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions

Exclusion Criteria:

1. Allergy or sensitivity to adhesive used for wearing the investigational device
2. Self-reported use of a pacemaker
3. Self-reported unstable diagnosed anxiety disorder
4. Self-reported sleep disorder requiring medical treatment
5. Self-reported skin conditions or sensitive skin around the area of application
6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
7. Alcohol intake average of ˃1 standard drink per day
8. Alcohol or drug abuse within the last 12 months that has required treatment
9. Current use of prescribed and/or over-the-counter (OTC) medications/supplements that may impact data recorded by the investigational device (see Section 7.3)
10. Participation in other clinical research studies 30 days prior to screening
11. Individuals who are unable to give informed consent
12. Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Where it's running

• KGK Science Inc.
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Crowley, MD — KGK Science Inc.
• Study coordinator: Marc Moulin, PhD
• Email: mmoulin@kgkscience.com
• Phone: +12267819094;ext=300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotic Intake to See If It Helps Perimenopausal Women Think and Feel Better

  We’re testing whether a multi-strain probiotic can improve emotional processing and cognitive function in perimenopausal women who have mood or cognitive concerns.

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• Understanding immune clues to depression in perimenopause

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• Hop extract vs soy isoflavone for menopausal symptoms

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  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Plant extract supplement for menopausal symptoms in women around menopause

  A plant-extract dietary supplement is being tested to see if it helps hot flashes and related symptoms in women aged 42–60 who are nearing or just past menopause, compared with a placebo.

  Recruiting University of Alicante · Elche, Alicante · NCT07863973

• Lifestyle changes to ease menopausal symptoms, sleep problems, and anxiety

  Researchers are testing whether a structured lifestyle education program helps perimenopausal and postmenopausal women see fewer menopausal symptoms, better sleep, and less anxiety compared to usual care.

  Recruiting Konya Beyhekim Training and Research Hospital · Konya, Konya · NCT07860645

• Inulin Prebiotic for Perimenopausal Women with Overweight or Obesity

  This study tests whether 2 weeks of inulin can affect gut and vaginal microbes, heart health, and muscle health in perimenopausal women who are overweight or obese, using a crossover design.

  Recruiting George Washington University · Washington D.C., District of Columbia · NCT07724522

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.