What this trial studies
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 in scope
- Perimenopause
- Perimenopausal Depression
- Perimenopausal Insomnia
- Perimenopausal Women
- Menopausal Depression
- Menopausal Hot Flashes
- Menopausal and Postmenopausal Disorders
- Menopausal Vasomotor Symptoms
Interventions
- Not specified in the public record.
Who can join
Women only · Ages 35 Years to 55 Years
Inclusion criteria
- Females between 35-55 years of age, inclusive
- Self-reported perimenopausal women experiencing hot flushes or night sweats
- 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
Exclusion criteria
- Allergy or sensitivity to adhesive used for wearing the investigational device
- Self-reported use of a pacemaker
- Self-reported unstable diagnosed anxiety disorder
- Self-reported sleep disorder requiring medical treatment
- Self-reported skin conditions or sensitive skin around the area of application
- Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
- Alcohol intake average of ˃1 standard drink per day
- Alcohol or drug abuse within the last 12 months that has required treatment
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| London | Ontario | KGK Science Inc. | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Observational
- Phase: N/A
- Start date: 2025-07-04
- Primary completion: 2025-10
- Last update posted: 2025-09-18
- First posted: 2025-06-15
Sponsor & contact
Lead sponsor: IdentifyHer Limited (Industry)
Collaborators: KGK Science Inc.
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms. (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 vasomotor symptoms. Questionnaire answers include "not at all" to "extremely". - The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety (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. Questionnaire answers include "not at all" to "nearly everyday". - The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality (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. Questionnaire answers include "terrible" to "very well". - 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 (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 of warmer environmental conditions. Questionnaire answers include "not at all" to "nearly all day". - 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 (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 of an ethnically-diverse study population. Questionnaire answers include "not at all" to "nearly all day".
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07022925 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.