Spire Medical Health Tag Respiratory Rate Validation in Adults
Public ClinicalTrials.gov record NCT04104737. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag. The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.
Study identification
- NCT ID
- NCT04104737
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 3, 2019
- Primary completion
- Jun 12, 2019
- Completion
- Jun 12, 2019
- Last update posted
- Oct 29, 2019
2019
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spire, Inc. | San Francisco | California | 94110 | — |
| Arthur Cabrera, MD. | Louisville | Colorado | 80027 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04104737, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04104737 live on ClinicalTrials.gov.