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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess device prototype functionality | Other | Everyone will be in the same arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDA approved pulse oximeter and DOVE device prototype | Device | The objective is to assess reasonable detection of hypoxic episodes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Arm | A convenience sample of 27 patients who presented for overnight polysomnogram. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Arm | A convenience sample of 27 patients who presented for overnight polysomnogram |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 participants had a corrupted data file. 1 patient had the device applied without an SD card. The remaining 24 patients were analyzed. | Posted | Mean | 95% Confidence Interval | percentage points | 15 hours | "SpO2 Values | "SpO2 Values |
|
from enrollment until end of follow-up, up to 16 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Arm | A convenience sample of 27 patients who presented for overnight polysomnogram |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cameron Baston | University of Pennsylvania | 2679096563 | cameron.baston@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Dec 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2022 | Dec 9, 2025 | ICF_001.pdf |
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| 15-20 minutes depending on the patients questions. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Body mass index | Mean | Inter-Quartile Range | kilogram per meter squared |
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| Secondary | 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. | Posted | Mean | Inter-Quartile Range | Score on a scale | 15-20 minutes depending on the patients questions. |
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| 27 |
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| 27 |
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