NCT03797300

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 days

First QC Date

January 2, 2019

Last Update Submit

January 7, 2019

Conditions

HypoxiaHypercapniaHypocapnia

Outcome Measures

Primary Outcomes (2)

  • Accuracy of SpO2 measurement

    Pulse oximetry measurement accuracy vs. gold standard

    duration of subject monitoring, usually up to one hour

  • Accuracy of Respiratory Rate measurement

    Respiratory rate measurement accuracy vs. gold standard

    duration of subject monitoring, usually up to one hour

Study Arms (1)

Primary

EXPERIMENTAL
Device: Spry Loop Band

Interventions

Spry Loop BandDEVICE

Loop band measures pulse oximetry and respiration rate

Primary

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult willing to participate

You may not qualify if:

  • Wrist size outside the indicated use
  • Low perfusion
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Hypoxia Lab

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

HypoxiaHypercapniaHypocapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 9, 2019

Study Start

December 12, 2018

Primary Completion

December 14, 2018

Study Completion

December 14, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)