Hypoxic Events
Conditions
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.
Interventions
DEVICEFDA approved pulse oximeter and DOVE device prototype
The objective is to assess reasonable detection of hypoxic episodes
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Error of Dove Device Compared to 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire About Comfort of Device | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years |
| Body mass index | 28.5 kilogram per meter squared |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
None listed