Pulmonary Disease, Chronic ObstructiveNCT01873092
AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
An observational study of Pulmonary Disease, Chronic Obstructive, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial summary
Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veteran patients with chronic obstructive pulmonary disease
Who may be able to join
- Veteran patients with a diagnosis of COPD or other chronic lung disease
- able to read and understand English
- > 45 years old
- ambulatory and able to perform functional testing
Who cannot join
- unable or unwilling to give informed consent
- daily use of a motorized cart
- impairment of cognition or communication
- history of drug or alcohol treatment within the past 6 months
- poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable
- Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time
Trial locations and contacts
1 site in 1 country.
United States1 site
VA, New York Harbor Healthcare Service
Brooklyn, New York, 11209
About this study
Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Oximetry, Physical Activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Patients who meet criteria for chronic obstructive pulmonary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory oximetry/activity profile
Oxygen saturation is measured with a pulse oximeter that has the capacity to collect data over 30- 34 hours; physical activity is measured with two pizo-electric accelerometers. Oximetry and activity data are synchronized to define a profile of oxygen saturation that is linked to usual daily activity.
Measured: Data is collected over 30-34 consecutive hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2003
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Miriam D Cohen, VA New York Harbor Healthcare System
- Investigators
- Miriam Cohen, Principal investigator, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873092
- Sponsor's protocol ID
- 00493
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen MD, Cutaia M. A novel approach to measuring activity in chronic obstructive pulmonary disease: using 2 activity monitors to classify daily activity. J Cardiopulm Rehabil Prev. 2010 May-Jun;30(3):186-94. doi: 10.1097/HCR.0b013e3181d0c191.
PubMed 20216326Cohen MD, Cutaia M, Brehm R, Brutus V, Pike VC, Lewendowski D. Detecting motor vehicle travel in accelerometer data. COPD. 2012 Apr;9(2):102-10. doi: 10.3109/15412555.2011.650238. Epub 2012 Mar 12.
PubMed 22409288Cutaia M, Brehm R, Cohen M. The relationship of the BODE index to oxygen saturation during daily activities in patients with chronic obstructive pulmonary disease. Lung. 2011 Aug;189(4):269-77. doi: 10.1007/s00408-011-9308-1. Epub 2011 Jun 24.
PubMed 21701832
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
- ClinicalTrials.gov ID
- NCT01873092
- Acronym / sponsor ID
- 00493
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Oximetry, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- May 2003
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jun 2013 (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.
Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | –Patients who meet criteria for chronic obstructive pulmonary disease |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veteran patients with chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- Veteran patients with a diagnosis of COPD or other chronic lung disease
- able to read and understand English
- > 45 years old
- ambulatory and able to perform functional testing
Key exclusion criteria (6 listed)
- unable or unwilling to give informed consent
- daily use of a motorized cart
- impairment of cognition or communication
- history of drug or alcohol treatment within the past 6 months
- poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable
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
Ambulatory oximetry/activity profile
Time frame: Data is collected over 30-34 consecutive hours
Oxygen saturation is measured with a pulse oximeter that has the capacity to collect data over 30- 34 hours; physical activity is measured with two pizo-electric accelerometers. Oximetry and activity data are synchronized to define a profile of oxygen saturation that is linked to usual daily activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Results publication: PubMed 20216326Cohen MD, Cutaia M. A novel approach to measuring activity in chronic obstructive pulmonary disease: using 2 activity monitors to classify daily activity. J Cardiopulm Rehabil Prev. 2010 May-Jun;30(3):186-94. doi: 10.1097/HCR.0b013e3181d0c191.
- Results publication: PubMed 22409288Cohen MD, Cutaia M, Brehm R, Brutus V, Pike VC, Lewendowski D. Detecting motor vehicle travel in accelerometer data. COPD. 2012 Apr;9(2):102-10. doi: 10.3109/15412555.2011.650238. Epub 2012 Mar 12.
- Results publication: PubMed 21701832Cutaia M, Brehm R, Cohen M. The relationship of the BODE index to oxygen saturation during daily activities in patients with chronic obstructive pulmonary disease. Lung. 2011 Aug;189(4):269-77. doi: 10.1007/s00408-011-9308-1. Epub 2011 Jun 24.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Miriam Cohen principal investigator
VA New York Harbor Healthcare System
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 Pulmonary Disease, Chronic Obstructive, run by VA New York Harbor Healthcare System 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Jun 2013. 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?
Results are not available in the source record.
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?
Ambulatory oximetry/activity profile (time frame: Data is collected over 30-34 consecutive hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873092, which also lists 3 linked publications.
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 7 Jun 2013.