Prevalence of OSA in COPD and the Clinical Impact of OSA Diagnosis and Treatment

NCT05042154 | Unknown

• 1 other identifier: 1753461-1
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

COPD is a major cause of morbidity and mortality and is characterized by breathing impairment and related symptoms. Obstructive sleep apnea (OSA) is a highly prevalent condition that adversely affects breathing during sleep. The co-occurrence of OSA and COPD in an individual has been referred to as the overlap syndrome (OVS). Regardless of whether OVS represents a single unique entity or two separate conditions in the same patient, the combined respiratory derangements of OSA and COPD are felt to be synergistic. Patients with COPD and OSA may have more frequent and severe nocturnal arterial hypoxemia and hypercapnia than in patients with OSA alone, as well as increased pulmonary hypertension and dysrhythmias. The reported prevalence of OSA in COPD varies widely depending on patient setting, COPD severity, diagnostic methodology, etc., ranging from 10 to 75%. The presence of OSA in patients with COPD has also been implicated as a risk factor for COPD exacerbations and associated hospitalizations. The coexistence of OSA and COPD is associated with increased risk of COPD exacerbation and shorter time to first exacerbation following diagnosis. 20% of patients discharged following an exacerbation of COPD are readmitted within 30 days, usually for respiratory-related problems. A randomized controlled trial on Gagnon 3 at Morristown Medical Center will be conducted to diagnose OSA in patients admitted with AECOPD. The WatchPAT One device will be used and can detect the presence of OSA. If OSA is diagnosed, the patient will then be offered and prescribed a home CPAP for use after hospital discharge. We will investigate 30-day of AECOPD readmission rates.

Conditions

Prevalence of OSA in Patients Hospitalized With COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• 30-Day Hospitals Readmissions for COPD

  30-Day Hospital Readmissions from the Index COPD Hospital Stay

  30 Days

Secondary Outcomes (1)

• Diagnosis of OSA

  48 hours

Study Arms (2)

Standard of Care Cohort for COPD

NO INTERVENTION

Standard care patients will receive routine clinical management as per their treating physicians based on the GOLD Criteria.

WatchPAT Cohort

ACTIVE COMPARATOR

Consented patients will undergo group randomization to either standard AECOPD care or to the WatchPAT One cohort (WPC). The WPC will undergo a single night of in-hospital sleep apnea testing from 2200 to 0600 using the WatchPAT One, a portable and disposable home sleep apnea testing device (Itamar Medical, Israel \[WPAT\]).

Device: WatchPAT

Interventions

WatchPAT DEVICE

The WatchPAT One can detect the presence of OSA based on measurement of peripheral arterial tone (PAT), pulse rate, oxygen saturation, actigraphy, snoring, and body position.

WatchPAT Cohort

Eligibility Criteria

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

You may not qualify if:

• We excluded patients unable or unwilling to participate in the home sleep study, medical problems or medications affecting the diagnostic accuracy/application of WatchPAT One (peripheral vascular disease, peripheral neuropathy, alpha blockade), admission to the ICU, finger deformity which prevented adequate sensor application.

Sponsors & Collaborators

• Atlantic Health System: lead

Central Study Contacts

Matthew Epstein, MD

CONTACT

862-432-2279; matthew.epstein@atlantichealth.org

Moira Kendra, DNP

CONTACT

908-403-3727

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 13, 2021
• Study Start: October 31, 2021
• Primary Completion: October 31, 2022
• Study Completion: January 1, 2023
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share