A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perimenopause, Perimenopausal Depression, Perimenopausal Insomnia, Perimenopausal Women. Basic parameters: 35 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
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
- 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 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- KGK Science Inc. — London
Identifiers
NCT: NCT07022925 · 24IDCFI01