NCT02048436

Brief Summary

The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

Same day

First QC Date

September 25, 2013

Last Update Submit

January 27, 2014

Conditions

Respiratory Rate Accuracy Test

Keywords

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

  • Respiratory Rate of test subject as compared to end tidal CO2

    1 week

Study Arms (1)

male female 18-45 years range of body types

18 male female subject mix that are 18-45 years of age and selected to represent a range of body types of varying physiques and body mass indexes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy Male or female, ages 18-45

You may qualify if:

  • male
  • female
  • range of physiques
  • healthy

You may not qualify if:

  • injury to sensor area
  • skin inflammation
  • implanted devices such as pacemakers
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinimark Laboratory

Louisville, Colorado, 80027, United States

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

January 29, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

US(1)