Hypoxic EventsNCT05197790
Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
A study testing FDA approved pulse oximeter and DOVE device prototype in people with Hypoxic Events, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypoxic Events
- What is being tested?
- FDA approved pulse oximeter and DOVE device prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females
- 21 years of age or older
- Suspected to suffer from hypoxic events
- Able to provide informed consent
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.
Read the 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.
- Conditions
- Hypoxic Events
- Being tested
- FDA approved pulse oximeter and DOVE device prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA approved pulse oximeter and DOVE device prototypeDevice
The objective is to assess reasonable detection of hypoxic episodes
| Study group | Role | What they receive |
|---|---|---|
| Assess device prototype functionality | Other | Everyone will be in the same arm Receives: Device: FDA approved pulse oximeter and DOVE device prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 hours
Secondary outcomes (1)
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.
Measured: 15-20 minutes depending on the patients questions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start20 May 2022
- Primary completion21 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypoxic EventsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197790
- Sponsor's protocol ID
- 849910
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2021
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
- ClinicalTrials.gov ID
- NCT05197790
- Acronym / sponsor ID
- 849910
- Conditions
- Hypoxic Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 17 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess device prototype functionality | Other | Device: FDA approved pulse oximeter and DOVE device prototypeEveryone will be in the same arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females
- 21 years of age or older
- Suspected to suffer from hypoxic events
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDA approved pulse oximeter and DOVE device prototypeThe objective is to assess reasonable detection of hypoxic episodes | Device | Assess device prototype functionality |
Primary outcome
Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor
Time frame: 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.
1 secondary outcome
Questionnaire About Comfort of Device
Time frame: 15-20 minutes depending on the patients questions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDA approved pulse oximeter and DOVE device prototype in people with Hypoxic Events, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor (time frame: 15 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.