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NCT06680700 · ClinicalTrials.gov registry record
Controlled Desaturation Study for Perin Health Patch Validation
A clinical trial of Oxygen Saturation Measurement, sponsored by Perin Health Devices.
- Recruiting
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT06680700: Recruiting study of Oxygen Saturation Measurement, sponsored by Perin Health Devices.
NCT06680700 is a study of Oxygen Saturation Measurement that is actively recruiting participants, run by Perin Health Devices. The registered enrollment target is 25 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06680700, a study of Oxygen Saturation Measurement, is actively recruiting participants, sponsored by Perin Health Devices.
- RECRUITING
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device. The PHP device uses light sensors to measure blood oxygen saturation (SpO2), similar to how standard pulse oximeters work, and could allow for continuous remote monitoring at home. Participants in this study will breathe low-oxygen air through a mask to simulate different oxygen levels in a controlled environment. The goal is to see if the PHP device can accurately measure blood oxygen levels under different conditions and meet safety standards set by the FDA and international guidelines.
Primary Outcome
The primary outcome measure is the accuracy of blood oxygen saturation (SpO2) readings from the Perin Health Patch (PHP) in comparison to those from a reference pulse oximeter. Accuracy will be determined by calculating the mean difference (bias) and standard deviation of differences (precision) between the SpO2 measurements obtained from the PHP and those from the reference devices across a range of hypoxemic conditions (70-100% SpO2). The PHP's SpO2 accuracy will be assessed using a root-mean
Conditions Studied
Interventions
- DEVICE Perin Health Patch
Study Locations (1)
California
- Perin Health Devices - Woodland Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2025-03-31 |
What NCT06680700 shows while recruiting
NCT06680700 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 1 condition, with Oxygen Saturation Measurement appearing as the primary indexed condition, and to 1 intervention - of which Perin Health Patch is the first listed.
NCT06680700 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06680700 about?
NCT06680700 is a clinical study titled "Controlled Desaturation Study for Perin Health Patch Validation". This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device. The PHP device uses light sensors to measure blood oxygen saturation (SpO2), similar to how standa...
What is the current status of trial NCT06680700?
This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2024-10-21. Estimated completion is 2025-03-31.
What conditions does trial NCT06680700 study?
This clinical trial studies the following conditions: Oxygen Saturation Measurement.
What interventions are being tested in trial NCT06680700?
The interventions under investigation include: Perin Health Patch (DEVICE).
Who is sponsoring clinical trial NCT06680700?
This trial is sponsored by Perin Health Devices, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06680700 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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