Phenotypic Measurements and Their Relation to Disease Exa... | NCT03300739

Studies
Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

NCT03300739

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Sep 30, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

COPD Exacerbation
Copd

Interventions

Not provided

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Feb 2019Actual

Completion Date

Sep 2019Actual

First Submitted Date

Aug 23, 2017

First Submission Date that Met QC Criteria

Sep 28, 2017

First Posted Date

Oct 3, 2017Actual

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

Sep 27, 2020

Last Update Posted Date

Sep 30, 2020Actual

Name	Class
ResMed	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

Detailed Description

The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory rate (breaths per minute)	Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.	Daily, 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Oxygen saturation (%)	Collected via pulse oximeter.	Daily for 16 weeks
Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.	Collected via spirometer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days.
Sufficient understanding of the English language to be able to read and understand study procedures.

Exclusion Criteria:

Currently on admission in the hospital, on non-invasive positive airway pressure ventilation
Visual, hearing or cognitive impairments at the discretion of their physician.
Currently participating in a COPD telemonitoring program.
No AT&T cellular coverage at their primary residence
Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COPD diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Agboola, MD	MGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Partners Connected Health		Boston	Massachusetts	02114	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

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided