A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 55 years old?
Source: NCT07022925, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- IdentifyHer Limited
- Trial code
- NCT07022925
- Record updated
- 18 September 2025
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: Allergy or sensitivity to adhesive used for wearing the investigational device; Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study; 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; 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; 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; Self-reported use of a pacemaker; Alcohol intake average of ˃1 standard drink per day; Individuals who are unable to give informed consent.