NCT03592914

Brief Summary

Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

July 9, 2018

Last Update Submit

March 8, 2019

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3

    Measure respiratory rates

    40 minutes

Study Arms (1)

subjects with respiratory disease

This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who might be seen in a respiratory rehabilitation center.

You may qualify if:

  • The subject is at least 18 years old;
  • The subject has given written informed consent to participate in the study;
  • The subject is both willing and able to comply with study procedures.

You may not qualify if:

  • The subject has a history of or current atrial fibrillation;
  • The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds;
  • The subject has an implanted pacemaker;
  • The subject has had any relevant injury at the sensor location site (self-reported);
  • The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
  • The subject is currently or trying to get pregnant (self-reported); and/or
  • The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nonin Medical, Inc.

Plymouth, Minnesota, 55441, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

July 31, 2018

Primary Completion

January 16, 2019

Study Completion

January 16, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

US(1)