This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Sponsor VA New York Harbor Healthcare System
Start date May 2003
End date December 2014
Trial size 100 participants
Trial identifier NCT01873092, 00493


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients who meet criteria for chronic obstructive pulmonary disease

Primary Outcomes

Ambulatory oximetry/activity profile
time frame: Data is collected over 30-34 consecutive hours

Eligibility Criteria

Male or female participants at least 45 years old.

Inclusion Criteria: 1. Veteran patients with a diagnosis of COPD or other chronic lung disease 2. able to read and understand English 3. > 45 years old 4. ambulatory and able to perform functional testing Exclusion Criteria: 1. unable or unwilling to give informed consent 2. daily use of a motorized cart 3. impairment of cognition or communication 4. history of drug or alcohol treatment within the past 6 months 5. poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable 6. Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time

Additional Information

Official title AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Principal investigator Miriam Cohen
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by VA New York Harbor Healthcare System.