Early Detection of COPD Exacerbations Using Home Monitori... | NCT07554352

Studies
Early Detection of COPD Exacerbations Using Home Monitoring Device

NCT07554352

Sponsor

RespirAI US Inc

Status

Not yet recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

COPD Exacerbation

Interventions

RespirAI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 21, 2026

First Posted Date

Apr 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age >21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High risk COPD patients		Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.	Device: RespirAI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RespirAI	Device	Use of a software-based monitoring device for 6 months.	High risk COPD patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity	Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device	6 months
False alam rate	The rate of false alarms produced by the device.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >21 years.
Physician-diagnosed COPD at least 6 months prior to screening visit.
Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.
Free of exacerbation for 1 month before enrollment.

Exclusion Criteria:

Unable or willing to sign an informed consent.
Unable to complete the 6-minute walk test due to physical or mental health conditions.
Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.
Pregnancy
Study clinician determines that the patient is unable or unwilling to comply with all study procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults aged 21 and older with physician-diagnosed COPD who are at high risk for exacerbations.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tamar Sobol	Contact	(617) 615-6799‬		info@respriai.com

Overall Officials

Name	Affiliation	Role
Adam D Wells, MD, FCCP	Nebraska Methodist Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Physicians Clinic		Omaha	Nebraska	68114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided