NCT05197790

Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device

A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.

Detailed description

After informing the patient about the study and the potential risk. The patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. The day of the enrolment is when the visit will be completed. The patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.

Conditions

• Hypoxic Events

Interventions

Type	Name	Description
DEVICE	FDA approved pulse oximeter and DOVE device prototype	The objective is to assess reasonable detection of hypoxic episodes

Timeline

• Start date: 2022-05-20
• Primary completion: 2024-12-21
• Completion: 2024-12-28
• First posted: 2022-01-20
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study