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

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

Study Overview

• Status: Recruiting
• Conditions: Hypoxic Events
• Intervention / Treatment: Device: FDA approved pulse oximeter and DOVE 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob S Brenner, MD, PHD; Phone Number: 650-799-7024; Email: Jacob.Brenner@pennmedicine.upenn.edu
• Study Contact Backup: Name: Haideliza Soto-Calderon; Phone Number: 2152209425; Email: haideliza.soto-calderon@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assess device prototype functionality; Everyone will be in the same arm	Device: FDA approved pulse oximeter and DOVE device prototype; The objective is to assess reasonable detection of hypoxic episodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing Dove device against 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.	15 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire about comfort of device	Participant will be surveyed for their subjective comfort wearing the DOVE prototype device. The questionnaire will ensure topics such as compliance and comfort or any issues and experiences the subject had with the prototype device.	15-20 minutes depending on the patients questions.

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Estimated): December 21, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 849910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No