Cycle and Ovulation Study Expansion

Apple

Status: Completed

Conditions: Menstruation

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05852951

Pro00054031

Details and patient eligibility

About

The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.

Enrollment: 698 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)
• Can communicate in written and spoken English
• Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi
• Access to reliable Wifi in the bedroom
• Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype
• Able to read and understand the written consent form
• Reside in the US for the duration of the study

Trial design

698 participants in 1 patient group

Menstrual patterns

Description:

Regular menstrual cycles and irregular menstrual cycles; irregular menstrual cycles are defined as having variation in menstrual cycles of greater than 2 days and less than 2 months