Pulmonary Disease, Chronic ObstructiveNCT03030313
Respiration Rate Monitoring in COPD Patients
A study testing Reassure Non-Contact Respiration Monitor in people with Pulmonary Disease, Chronic Obstructive, run by ResMed at 1 site in United States.
Trial summary
Assess the feasibility of using remote respiration rate monitoring as a component of home care, how respiration rate data may be used in combination with other data to potentially improve response to symptoms, and to generate data to inform the endpoints and effect sizes of future studies. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Reassure Non-Contact Respiration Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 26 Jul 2017
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age ≥35 years old
- Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- Weight ≥35 kg
- Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
- Must be able to read and understand English and consent for themselves
Who cannot join
- Currently using any form of non-invasive positive airway pressure ventilation
- Diagnosis of significant heart failure (NYHA Class III or IV)
- Cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
- BMI ≥45.5
- Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- Currently using a wearable drug infusion pump to deliver medication
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- Planned procedures at time of enrollment that will occur within timeframe of study and require hospitalization etc.
- Declines to participate at any time.
- In the opinion of the Investigator, may be non-compliant with study schedules or procedures
- No cellular coverage at their primary residence
Trial locations and contacts
1 site in 1 country.
United States1 site
HGE Health Care Solutions
Philadelphia, Pennsylvania, 19129
About this study
Official title: Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients
Assess the feasibility of using remote respiration rate monitoring as a component of home care, how respiration rate data may be used in combination with other data to potentially improve response to symptoms, and to generate data to inform the endpoints and effect sizes of future studies.
Read the detailed description
The research question is whether monitoring of respiration rates and variability can be helpful in management of COPD patients in conjunction with or separately from self-reported symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's self-reported symptoms) have limited sensitivity and specificity with regard to predicting decompensation. Measurement of respiration parameters and the variability of the parameters may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow an opportunity for earlier intervention with medical assessment and current therapeutic approaches.
The specific primary aim includes evaluation of the correlation of respiration rate parameters to indicators of healthcare utilization including drug changes, office or ER visits, hospitalization, or other clinical interventions. Secondary aims include evaluation of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict COPD worsening requiring medical intervention, and the correlation of respiration rate parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Reassure Non-Contact Respiration Monitor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reassure Non-Contact Respiration MonitorDevice
Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage.
| Study group | Role | What they receive |
|---|---|---|
| Respiration rate monitoring | Experimental | Reassure Non-Contact Respiration Monitor Receives: Device: Reassure Non-Contact Respiration Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Respiration Rate to Indicators of Healthcare Utilization
Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
Measured: 12 weeks
Secondary outcomes (3)
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Measured: Baseline to 12 weeks
Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
Measured: 12 weeks
Correlation of Respiration Rate to COPD Episode Duration
Episode duration is defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Dec 2016
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030313
- Sponsor's protocol ID
- MA-16-05-01
- Status last verified
- Nov 2017
- First submitted
- 18 Nov 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients
- ClinicalTrials.gov ID
- NCT03030313
- Acronym / sponsor ID
- MA-16-05-01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Assess the feasibility of using remote respiration rate monitoring as a component of home care, how respiration rate data may be used in combination with other data to potentially improve response to symptoms, and to generate data to inform the endpoints and effect sizes of future studies.
Detailed description
The research question is whether monitoring of respiration rates and variability can be helpful in management of COPD patients in conjunction with or separately from self-reported symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's self-reported symptoms) have limited sensitivity and specificity with regard to predicting decompensation. Measurement of respiration parameters and the variability of the parameters may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow an opportunity for earlier intervention with medical assessment and current therapeutic approaches.
The specific primary aim includes evaluation of the correlation of respiration rate parameters to indicators of healthcare utilization including drug changes, office or ER visits, hospitalization, or other clinical interventions. Secondary aims include evaluation of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict COPD worsening requiring medical intervention, and the correlation of respiration rate parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiration rate monitoring | Experimental | Device: Reassure Non-Contact Respiration MonitorReassure Non-Contact Respiration Monitor |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females age ≥35 years old
- Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- Weight ≥35 kg
- Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
- Must be able to read and understand English and consent for themselves
Key exclusion criteria (10 listed)
- Currently using any form of non-invasive positive airway pressure ventilation
- Diagnosis of significant heart failure (NYHA Class III or IV)
- Cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
- BMI ≥45.5
- Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reassure Non-Contact Respiration MonitorReassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage. | Device | Respiration rate monitoring |
Primary outcome
Correlation of Respiration Rate to Indicators of Healthcare Utilization
Time frame: 12 weeks
Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
3 secondary outcomes
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Time frame: Baseline to 12 weeks
Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
Time frame: 12 weeks
Correlation of Respiration Rate to COPD Episode Duration
Time frame: 12 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 17 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Gerard Criner, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reassure Non-Contact Respiration Monitor in people with Pulmonary Disease, Chronic Obstructive, run by ResMed 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 5 inclusion and 10 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 17 Nov 2017. 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?
Correlation of Respiration Rate to Indicators of Healthcare Utilization (time frame: 12 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 17 Nov 2017.