Validating Terra, a device for closed-loop hot-flash cooling relief and sleep improvement

Vasomotor symptoms (VMS), including nighttime hot flashes, significantly impact the well-being of 80% of menopausal women, leading to sleep disturbances, reduced quality of life, and an elevated risk of developing chronic diseases such as diabetes, depression, and cardiovascular disorders. While hormone replacement therapy (HRT) offers a common solution, its associated health risks prompt the search for safer, more effective treatments. Traditional remedies and cooling products provide partial relief but lack the ability to dynamically respond to VMS, often failing to prevent sleep disruption effectively. Amira introduces Terra, a pioneering sleep technology designed to address these challenges through an innovative closed-loop temperature control system. Terra distinguishes itself by utilizing smart wearable sensors to detect the onset of hot flashes in real-time and employing targeted cold bursts instead of continuous cooling, offering a personalized and more comfortable cooling experience throughout the night. This approach not only aims to mitigate hot flashes but also optimizes overall sleep temperature, adapting to the user’s changing needs across different sleep stages. The Terra platform leverages a combination of biofeedback, advanced electrode technology, and machine learning algorithms to accurately predict and respond to VMS, ensuring rapid cooling in less than 5 seconds and significantly improving sleep quality by minimizing awakenings. Preliminary tests of proof-of-concept versions have validated the system's potential, demonstrating its capability to detect and preemptively counter hot flashes, thereby enhancing sleep quality. In the proposed Phase I SBIR study, Amira seeks to further evaluate Terra’s effectiveness through a comprehensive in-home study focusing on the accuracy of its biometric detection system and the efficacy of its closed-loop temperature control in managing VMS. This research will contribute to the development of a non-pharmacological, user-friendly solution for menopausal women, aligning with the mission to improve health outcomes by providing innovative responses to unmet medical needs. Project Number: 1R43AG087901-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Emilio Sison | Institution: AMIRA HEALTH INC., SOUTH SAN FRANCISCO, CA | Award Amount: $277,391 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZRG1 EMS-S (10)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11070109