Trial Outcomes & Findings for Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device (NCT NCT05197790)

NCT ID: NCT05197790

Last Updated: 2026-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

15 hours

Results posted on

2026-03-17

Participant Flow

3 patients had technical failures in the device's storage mechanism, and so their demographics and survey results are used, but their SpO2 data is not.

Participant milestones

Participant milestones
Measure	Primary Arm A convenience sample of 27 patients who presented for overnight polysomnogram.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Arm n=27 Participants A convenience sample of 27 patients who presented for overnight polysomnogram
Age, Continuous	55 years n=10 Participants
Sex: Female, Male Female	11 Participants n=10 Participants
Sex: Female, Male Male	16 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	2 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	8 Participants n=10 Participants
Race (NIH/OMB) White	17 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Region of Enrollment United States	27 Participants n=10 Participants
Body mass index	28.5 kilogram per meter squared n=10 Participants

PRIMARY outcome

Timeframe: 15 hours

Population: 2 participants had a corrupted data file. 1 patient had the device applied without an SD card. The remaining 24 patients were analyzed.

Outcome measures

Outcome measures
Measure	Primary Arm n=354002 "SpO2 Values A convenience sample of 27 patients who presented for overnight polysomnogram
Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor	0.45 percentage points Interval -3.04 to 3.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Primary Arm n=27 Participants A convenience sample of 27 patients who presented for overnight polysomnogram
Questionnaire About Comfort of Device	4.5 Score on a scale Interval 4.0 to 5.0

Adverse Events

Primary Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cameron Baston

University of Pennsylvania

Phone: 2679096563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place