HypoxiaNCT03797300
Pulse Oximeter and Respiratory Rate Test
A study testing Spry Loop Band in people with Hypoxia and Hypercapnia, run by Spry Health at 1 site in United States.
Trial summary
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia, Hypocapnia
- What is being tested?
- Spry Loop Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult willing to participate
Who cannot join
- Wrist size outside the indicated use
- Low perfusion
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia
- Conditions
- Hypoxia, Hypercapnia, Hypocapnia
- Being tested
- Spry Loop Band
- Medical subject headings
- Hypoxia, Hypercapnia, Hypocapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spry Loop BandDevice
Loop band measures pulse oximetry and respiration rate
| Study group | Role | What they receive |
|---|---|---|
| Primary | Experimental | Not described Receives: Device: Spry Loop Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of SpO2 measurement
Pulse oximetry measurement accuracy vs. gold standard
Measured: duration of subject monitoring, usually up to one hour
Accuracy of Respiratory Rate measurement
Respiratory rate measurement accuracy vs. gold standard
Measured: duration of subject monitoring, usually up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start12 Dec 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spry Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797300
- Sponsor's protocol ID
- SpryUCSF2
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia
- ClinicalTrials.gov ID
- NCT03797300
- Acronym / sponsor ID
- SpryUCSF2
- Conditions
- Hypoxia, Hypercapnia, Hypocapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Spry HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | Experimental | Device: Spry Loop Band |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult willing to participate
Key exclusion criteria (3 listed)
- Wrist size outside the indicated use
- Low perfusion
- Smoking
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 |
|---|---|---|
| Spry Loop BandLoop band measures pulse oximetry and respiration rate | Device | Primary |
Primary outcome
Accuracy of SpO2 measurement
Time frame: duration of subject monitoring, usually up to one hour
Pulse oximetry measurement accuracy vs. gold standard
Accuracy of Respiratory Rate measurement
Time frame: duration of subject monitoring, usually up to one hour
Respiratory rate measurement accuracy vs. gold standard
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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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 Spry Loop Band in people with Hypoxia and Hypercapnia, run by Spry Health 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 1 inclusion and 3 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 9 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of SpO2 measurement (time frame: duration of subject monitoring, usually up to one hour). The study lists 2 primary outcomes in all. 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 9 Jan 2019.