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

NCT05197790 | Completed Results FDA Device

• 1 other identifier: 849910
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxic Events

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor

  Dove device will be analyzed against FDA approved SpO2 and Skin tone will be incorporated as a factor of SpO2 function to ensure the device can be reasonably detect hypoxia. At each time point, the difference between the device and the FDA approved standard will be calculated. Mean average error will be used as a single summary statistic, and Bland-Altmann analysis will be used to graphically and numerically represent the limits of agreement.

  15 hours

Secondary Outcomes (1)

• Questionnaire About Comfort of Device

  15-20 minutes depending on the patients questions.

Study Arms (1)

Assess device prototype functionality

OTHER

Everyone will be in the same arm

Device: FDA approved pulse oximeter and DOVE device prototype

Interventions

FDA approved pulse oximeter and DOVE device prototype DEVICE

The objective is to assess reasonable detection of hypoxic episodes

Assess device prototype functionality

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females
• years of age or older
• Suspected to suffer from hypoxic events
• Able to provide informed consent

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Cameron Baston
• Organization: University of Pennsylvania

cameron.baston@pennmedicine.upenn.edu

2679096563

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 20, 2022
• Study Start: May 20, 2022
• Primary Completion: December 21, 2024
• Study Completion: December 28, 2024
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Locations

US (1)