Consequences of Nocturnal and Daytime Hypoxemia in COPD

NCT00547456 | Terminated Results

• 1 other identifier: 05.02.097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.

  4 weeks

Study Arms (1)

Decrease in oxygen level when sleeping

OTHER

Patients are their own controls and tested pre and post the addition of night time supplemental oxygen

Drug: Oxygen

Interventions

Oxygen DRUG

Oxygen 2-3L Nasal cannula

Decrease in oxygen level when sleeping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore LIJ Health System

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Rubin Cohen, MD
• Organization: North Shore LIJ Health System

rocohen@nshs.edu

516-465-5400

Study Officials

• Rubin Cohen, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 16, 2015
• Results First Posted: December 16, 2015

Record last verified: 2015-11

Locations

US (1)