Clinical trial NCT07022925: A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
Official title: An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perimenopause
Perimenopausal Depression
Perimenopausal Insomnia
Perimenopausal Women
Menopausal Depression
Menopausal Hot Flashes
Menopausal and Postmenopausal Disorders
Menopausal Vasomotor Symptoms
Keywords: Menopause
Perimenopause
Vasomotor symptoms
Hot flashes
IdentifyHer
Peri
Perimenopausal symptoms
Lead sponsor: IdentifyHer Limited
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2025-06-15
Enrollment: 110
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: N/A - virtual study. Participants are recruited online.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing Vasomotor symptoms
timeFrame: Day 0 to 14
measure: The accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing anxiety
timeFrame: Day 0 to 14
measure: The accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing sleep quality
timeFrame: Day 0 to 14
measure: The accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms considering confounders
timeFrame: Day 0 to 14
measure: The accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms considering confounders
timeFrame: Day 0 to 14
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: