Apple has completed the clinical trial for Cycle and Ovulation study expansion. The records were updated this week on the Govt. Clinical trials site.
This study is separate from Apple’s Women’s Health Study, conducted with the Harvard T.H. Chan School of Public Health and the National Institute of Environmental Health Sciences (NIEHS). This specific Ovulation and cycle expansion study was sponsored by Apple in collaboration with Exponent.
The Cycle and Ovulation Study Expansion trials started in 2021 and were completed last year. The records on the gov. database were updated this week and mention a ‘ hardware prototype wrist-worn sleep band”.
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.
Here are the major key dates of this clinical study:
698 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.
The study was completed in Phoenix, Arizona and spearheaded by Bo Qing from Exponent. He is a Biomedical engineering and sciences consultant.
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.
These trials were run in partnership with Exponent, an Engg. and research company with expertise in health sciences and human factors.
Most likely, the hardware wrist-worn sleep band is a lab control testing device. That being said, one wouldn’t be surprised if Apple develops a minimalistic sleep band. The problem with this assumption is that it will likely cannibalize Apple Watch sales.
When govt. records start getting updated a few weeks prior to WWDC; it is worth taking a deeper look 🙂