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

NCT ID: NCT05197790

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2024-12-28

Brief Summary

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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.

Detailed Description

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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

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Hypoxic Events

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Assess device prototype functionality

Everyone will be in the same arm

Group Type OTHER

FDA approved pulse oximeter and DOVE device prototype

Intervention Type DEVICE

The objective is to assess reasonable detection of hypoxic episodes

Interventions

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FDA approved pulse oximeter and DOVE device prototype

The objective is to assess reasonable detection of hypoxic episodes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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849910

Identifier Type: -

Identifier Source: org_study_id

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