Clinical trial NCT01873092: AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Official title: AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Oximetry
Physical Activity
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2013-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veteran patients with chronic obstructive pulmonary disease

Brief 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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory oximetry/activity profile
timeFrame: Data is collected over 30-34 consecutive hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: VA, New York Harbor Healthcare Service
state: New York
Study officials:
affiliation: VA New York Harbor Healthcare System
name: Miriam Cohen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cohen 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.
citation: Cutaia 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.