Résztvevőt keresFázis nélkül

A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women

A legfontosabb adatok

Ki végzi: IdentifyHer Limited
Hol: Kanada1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító: NCT07022925
Állapot: Toboroz
Résztvevők: 110 fő, tervezett
Kezdés: 2025. júl. 4.
Tervezett befejezés: 2025. okt.
A vizsgálat típusa: Megfigyeléses
A regiszteradat frissítve: 2025. szeptember 18.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for women aged 35 to 55 in perimenopause who have hot flushes or night sweats. They wear a skin sensor and fill in a daily app diary.

Életkor: 35 to 55 years
Nem: Women only
A betegség stádiuma: Perimenopause (self-reported) with hot flushes or night sweats. Generally healthy, with no unstable diagnosed medical conditions.
Korábbi kezelés: People cannot join if they take prescribed or over-the-counter medicines or supplements that may affect the device data.

A részvétel fő kizáró okai

Allergy or sensitivity to the device adhesive, or skin problems where the device is worn
Having a pacemaker
Unstable diagnosed anxiety disorder, or a sleep disorder needing medical treatment
Surgery in the past three months, or surgery planned during the study
Drinking more than 1 standard drink per day on average, or alcohol or drug abuse needing treatment in the last 12 months

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

35 és 55 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

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.