NCT02942836

Brief Summary

The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 20, 2016

Last Update Submit

October 21, 2016

Conditions

Respiration Rate Detection

Keywords

Respiration Rate Detection

Outcome Measures

Primary Outcomes (1)

  • Respiration rate detection with accuracy of better than 3 breaths per minute

    Comparison with performance of predicate device (accuracy within 3 breaths per minute).

    15 minutes of matched respiration rates

Interventions

non-intrusive respiration monitorDEVICE

Equivalence of CareTaker's respiration rate detection capability to that of predicate device

Eligibility Criteria

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

Subjects were local health club members, \> 18 years of age, who were able and willing to participate and willing to sign the written consent

You may qualify if:

  • \> 18 years of age, who are able and willing to participate and have given verbal assent

You may not qualify if:

  • Unable to give written consent
  • \<18 years of age
  • No or poor finger pulse, as determined through visual inspection for ischemic hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Martin C Baruch, PhD

    CareTaker Medical LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 24, 2016

Record last verified: 2016-10