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

N/ACompletedNCT05197790

University of Pennsylvania27 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypoxic Events

Interventions

FDA approved pulse oximeter and DOVE device prototypeDEVICE

The objective is to assess reasonable detection of hypoxic episodes

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 15 hours

Secondary Outcomes

Questionnaire About Comfort of Device

We assessed the prototypes based on comfort via a 5-point Likert scale and an open-ended qualitative questionnaire. The Likery scale specific to the comfort of the device ranged from 1 (Very uncomfortable) to 5 (very comfortable. Higher values are considered to be better outcomes. Participant will be surveyed with open ended questions 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.

Time frame: 15-20 minutes depending on the patients questions.

Data from ClinicalTrials.gov

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