PerimenopauseNCT07022925
A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
An observational study of Perimenopause and Perimenopausal Depression, run by IdentifyHer Limited at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Perimenopause, Perimenopausal Depression, Perimenopausal Insomnia
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2025to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: N/A - virtual study. Participants are recruited online.
Who may be able to join
- 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)
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- Vasectomy of partner at least 6 months prior to screening
- Abstinence
- Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
- Provided voluntary and informed consent to participate in the study
- Generally healthy as determined by medical history with no unstable diagnosed medical conditions
Who cannot join
- 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
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- Alcohol intake average of ˃1 standard drink per day
- Alcohol or drug abuse within the last 12 months that has required treatment
- 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)
- Participation in other clinical research studies 30 days prior to screening
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Marc Moulin, PhD, +12267819094;ext=300, mmoulin@kgkscience.com
David Crowley, MD, dcrowley@kgkscience.com
About this study
Official title: An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
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, Menopausal Hot Flashes
- Keywords
- Menopause, Perimenopause, Vasomotor symptoms, Hot flashes, IdentifyHer, Peri, Perimenopausal symptoms
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms.
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".
Measured: 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
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".
Measured: 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
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".
Measured: 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
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".
Measured: 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
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".
Measured: Day 0 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start4 Jul 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IdentifyHer Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022925
- Sponsor's protocol ID
- 24IDCFI01
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
- ClinicalTrials.gov ID
- NCT07022925
- Acronym / sponsor ID
- 24IDCFI01
- Conditions
- Perimenopause, Perimenopausal Depression, Perimenopausal Insomnia, Perimenopausal Women, Menopausal Depression, Menopausal Hot Flashes
- Keywords
- Menopause, Perimenopause, Vasomotor symptoms, Hot flashes, IdentifyHer, Peri, Perimenopausal symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- IdentifyHer LimitedIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- N/A - virtual study. Participants are recruited online.
Key inclusion criteria (11 listed)
- 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:
- Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
- Provided voluntary and informed consent to participate in the study
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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
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. 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
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. 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
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 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
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 of an ethnically-diverse study population. Questionnaire answers include "not at all" to "nearly all day".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause and Perimenopausal Depression, run by IdentifyHer Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Moulin, PhD (+12267819094;ext=300, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.