Recruiting

Observational Study

Sponsor:

IdentifyHer Limited

Code:

NCT07022925

Conditions

Perimenopause

Perimenopausal Depression

Perimenopausal Insomnia

Perimenopausal Women

Menopausal Depression

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to investigate the accuracy of the device in characterizing perimenopausal and menopausal symptoms including vasomotor symptoms, anxiety, sleep quality compared to self-reported symptoms via an app. The main question it aims to answer is:

What is the accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms?

Participants will be asked to wear IndentifyHer's wearable non-invasive sensor and complete a daily electronic diary and questionnaires on stress, anxiety, and sleep.

Conditions

Perimenopause

Perimenopausal Depression

Perimenopausal Insomnia

Perimenopausal Women

Menopausal Depression

Study ID

NCT07022925

Start date

Jul 4, 2025

Status verified date

Jun, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

IndentifyHer's Peri

IndentifyHer's Peri investigational device is a commercial, non-invasive, wearable sensor that works in combination with a digital platform to quantify and profile the frequency and severity of perimenopausal symptoms including hot flashes, night sweats, anxiety, and sleep disturbances.

Primary outcome measure

  • The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms. [ Time Frame: Day 0 to 14 ]
  • The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety [ Time Frame: Day 0 to 14 ]
  • The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality [ Time Frame: Day 0 to 14 ]
  • The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders [ Time Frame: Day 0 to 14 ]
  • The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders [ Time Frame: Day 0 to 14 ]

Central Contacts and Locations

Central contacts

Locations

KGK Science Inc.

Recruiting

London, Ontario, Canada, N6B3L1

Contacts

Principal Investigator:

David Crowley, MD

More Information

Sponsor

IdentifyHer Limited

Last update posted

Sep 18, 2025

Last verified

Jun, 2025

Keywords

  • Menopause
  • Perimenopause
  • Vasomotor symptoms
  • Hot flashes
  • IdentifyHer
  • Peri
  • Perimenopausal symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IdentifyHer Limited on 2025-09-18.