COPD ExacerbationNCT03300739
Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients
An observational study of COPD Exacerbation and Copd, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Copd
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD diagnosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Connected Health
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- COPD Exacerbation, Copd
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily, 16 weeks
Secondary outcomes (12)
Oxygen saturation (%)
Collected via pulse oximeter.
Measured: 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
Measured: Weekly for16 weeks
Physical activity
Collected via step counts
Measured: Daily for 16 weeks
Body Mass Index (kg/m^2)
Weight and height will be combined to report BMI
Measured: Baseline (Day 0) and Close-out (16 weeks)
Quality of life
Collected via SF-12 questionnaire
Measured: Baseline (Day 0) and Close-out (16 weeks)
Depression
Collected via PHQ-8 questionnaire
Measured: Monthly for 16 weeks
Anxiety
Collected via GAD-7 questionnaire
Measured: Baseline (Day 0) and Close-out (16 weeks)
COPD symptom assessment
Collected via CAT questionnaire
Measured: Weekly for 16 weeks
Functional impairment due to dyspnea
Collected via mMRC dyspnea scale
Measured: Weekly for 16 weeks
Study device usability
Collected via usability questionnaire
Measured: Close-out (16 week)
Medical treatment
Collected via electronic health record
Measured: Baseline (Day 0) and Close-out (16 weeks)
Hospitalization records
Collected via electronic health record
Measured: Baseline (Day 0) and Close-out (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study startDec 2016
- Primary completionFeb 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Stephen Agboola, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300739
- Sponsor's protocol ID
- 2016P002312
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2017
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients
- ClinicalTrials.gov ID
- NCT03300739
- Acronym / sponsor ID
- 2016P002312
- Conditions
- COPD Exacerbation, Copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD diagnosis
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory rate (breaths per minute)
Time frame: Daily, 16 weeks
Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.
12 secondary outcomes
Oxygen saturation (%)
Time frame: Daily for 16 weeks
Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.
Time frame: Weekly for16 weeks
Physical activity
Time frame: Daily for 16 weeks
Body Mass Index (kg/m^2)
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Quality of life
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Depression
Time frame: Monthly for 16 weeks
Anxiety
Time frame: Baseline (Day 0) and Close-out (16 weeks)
COPD symptom assessment
Time frame: Weekly for 16 weeks
Functional impairment due to dyspnea
Time frame: Weekly for 16 weeks
Study device usability
Time frame: Close-out (16 week)
Medical treatment
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Hospitalization records
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Agboola, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and Copd, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (breaths per minute) (time frame: Daily, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.