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Healthy Cohort for Cardiopulmonary Diseases

Phase 2

Waitlist Available

Research Sponsored by Analog Device, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trialtests how accurately a device measures respiration rate & changes in tidal volume during exercises. Participants randomly do 4 procedures of 10 exercises each. Devices measure their breathing for two mins, then rest for two mins. Some exercises require breathing at a certain rate.

Eligible Conditions

Cardiopulmonary Diseases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accuracy of CPM System calculated RR versus reference device

Accuracy of the changes in the rTV calculated by CPM System compared to reference TV, if data is available.

Secondary outcome measures

Accuracy of CPM system calculated RR compared to reference device

ECG confirmation.

Skin temperature confirmation.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Healthy CohortExperimental Treatment1 Intervention

The target population for this cohort is healthy adult volunteers who do not have preexisting heart or lung conditions or illness. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders and compare the reference device measurements to the test device.

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Who is running the clinical trial?

Analog Device, Inc.Lead Sponsor

12 Previous Clinical Trials

1,991 Total Patients Enrolled

Clayton Sleep InsitituteIndustry Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with using Healthy Cohort as a treatment?

"Our team at Power gave Healthy Cohort a safety rating of 2, as the Phase 2 trial has only collected data on its safety, and not yet established efficacy."

Answered by AI

Is this experiment recruiting new participants at present?

"According to the clinicaltrials.gov website, this medical study is not actively accepting participants at present. Initially posted on June 22nd 2022 and last updated on January 31st 2023, it appears that no new patients are being recruited for this trial; however, there are 5 alternatives trials currently welcoming applicants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Respiration Validation for CPM Device

2022. "Respiration Validation for CPM Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445492.