NCT05276362

Study Watch Sleep Metric Performance Characterization Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Verily Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, single-arm, prospective performance evaluation study designed to assess performance of sleep metrics calculated from sensor data that is collected from two versions of the Verily Study Watch as compared to polysomnography.

Conditions

• Sleep
• Obstructive Sleep Apnea
• Insomnia

Interventions

Type	Name	Description
DEVICE	Study Watch	The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.
DEVICE	Actiwatch	The Actiwatch is a wrist worn activity device designed to collect general activity and sleep information. This device received 510(k) clearance from the FDA as a wearable medical data collection device for research and clinical use.

Timeline

• Start date: 2022-03-04
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2022-03-11
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study