Menopausal and Postmenopausal Disorders, Menopausal Depression, Menopausal Hot Flashes, Menopausal Vasomotor Symptoms, Perimenopausal Depression, Perimenopausal Insomnia, Perimenopausal Women, Perimenopause
Conditions
Keywords
Menopause, Perimenopause, Vasomotor symptoms, Hot flashes, IdentifyHer, Peri, Perimenopausal symptoms
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.
Interventions
None listed
Sponsors
KGK Science Inc.
IdentifyHer Limited
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactMarc Moulin, PhD
Outcome results
None listed