Consequences of Nocturnal and Daytime Hypoxemia in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547456
• Other study ID #: 05.02.097
• Status: Terminated
• Phase: N/A
• First received: October 18, 2007
• Last updated: November 13, 2015
• Start date: October 2005
• Est. completion date: June 2013

Study information

• Verified date: November 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We will determine whether oxygen therapy lowers the level of substances in the blood which cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves overall well being and quality of life as well as sleep quality.

Description:

Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.

• Clinical stability defined by absence of treatment change or need for acute care within the last two months.

• Weight stable, within 5%, in the previous three months as measured during office visits.

• Willingness to participate in a clinical study.

Exclusion Criteria:

• Acute illness within the preceding 2 months.

• Patients who received systemic glucocorticoid therapy within the past month.

• Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.

• Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas

• Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.

• No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.

• Primary care or pulmonary physician refusal.

• Patient refusal for any reason.

• Lack of capacity to participate in the informed consent process.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Oxygen
Oxygen 2-3L Nasal cannula

Locations

Country	Name	City	State
United States	North Shore LIJ Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.		4 weeks	No