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

University of Pennsylvania

Status: Completed

Conditions: Hypoxic Events

Treatments: Device: FDA approved pulse oximeter and DOVE device prototype

Study type: Interventional

Funder types: Other

Identifiers

NCT05197790

849910

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Assess device prototype functionality

Other group

Description:

Everyone will be in the same arm

Treatment:

Device: FDA approved pulse oximeter and DOVE device prototype