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

Not Applicable

Recruiting

• Conditions: Hypoxic Events
• Interventions: Device: FDA approved pulse oximeter and DOVE device prototype

• Registration Number: NCT05197790
• Lead Sponsor: University of Pennsylvania

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-20
• Study Start: 2022-05-20
• Status Verified: 2023-12
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-12-21
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Read More

Exclusion Criteria

• Pregnant

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess device prototype functionality	FDA approved pulse oximeter and DOVE device prototype	Everyone will be in the same arm

Primary Outcome Measures

Name	Time	Method
Comparing Dove device against FDA approved SpO2 sensor	15 hours	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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire about comfort of device	15-20 minutes depending on the patients questions.	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.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States