NCT05197790

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

Completed NA Results posted Last updated 17 March 2026

What this trial tests

NA trial testing FDA approved pulse oximeter and DOVE device prototype in Hypoxic Events in 27 participants. Completed in 28 December 2024.

Timeline

20 May 2022

Primary endpoint
21 December 2024

28 December 2024

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	27
Start date	20 May 2022
Primary completion	21 December 2024
Estimated completion	28 December 2024
Sites	1 location across United States

Drugs / interventions tested

• FDA approved pulse oximeter and DOVE device prototype

Conditions studied

• Hypoxic Events — all drugs for Hypoxic Events →

Sponsor

University of Pennsylvania

Who can join

21 and older, any sex, with Hypoxic Events. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor Primary · 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. 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.

Group	Value	95% CI
Primary Arm	0.45	-3.04 – 3.13

Questionnaire About Comfort of Device Secondary · 15-20 minutes depending on the patients questions.

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.

Group	Value	95% CI
Primary Arm	4.5	4 – 5

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.