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Search / Trial NCT06390345

Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

Launched by SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH · Apr 25, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a telehealth program can help improve the health and quality of life for people who have both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The trial will involve 400 overweight and obese patients who are receiving care at specific Veterans Affairs medical centers. Participants will be randomly assigned to either a special telehealth intervention, which includes a lifestyle program and supervised exercise, or to enhanced usual care, where their primary care doctors will refer them to existing programs for weight management and rehabilitation. The researchers will check in with participants after 3 and 12 months to see how their quality of life has improved.

To be eligible for this study, participants must have COPD, a history of sleep apnea, and a body mass index (BMI) of 25 or higher. They should also experience shortness of breath during daily activities. It's important to note that individuals who have recently lost a significant amount of weight, are currently in weight loss programs, or have certain health conditions may not be able to participate. Throughout the study, those in the telehealth group will have access to a lifestyle coach, and all participants will have virtual visits to monitor their progress.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • COPD: Defined by presence of airflow obstruction (FEV1/FVC \< 0.70) on post-bronchodilator spirometry
  • ≥10 pack year history of tobacco use
  • Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
  • BMI ≥ 25 kg/m2
  • Symptoms of dyspnea defined by MMRC score of ≥1
  • Exclusion Criteria:
  • Self-report of weight change \>15 lbs. during prior 3 months
  • Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
  • Severe illness from any cause
  • Diagnosis of bulimia or history of purging behavior
  • Active enrollment in pulmonary rehabilitation
  • Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \< 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
  • Pregnant, lactating, or planning to become pregnant during the study period
  • Participation in other intervention studies.
  • Prisoner
  • Unable to complete surveys in English

About Seattle Institute For Biomedical And Clinical Research

The Seattle Institute for Biomedical and Clinical Research is a leading nonprofit organization dedicated to advancing medical science through innovative research and clinical trials. With a strong focus on translating laboratory discoveries into effective therapies, the Institute collaborates with academic institutions, healthcare providers, and industry partners to address pressing health challenges. Its multidisciplinary approach encompasses a wide range of therapeutic areas, including oncology, neurology, and infectious diseases, ensuring that cutting-edge research is aligned with patient needs. Committed to fostering a culture of scientific excellence and integrity, the Institute plays a pivotal role in shaping the future of biomedical research and improving patient outcomes.

Locations

Minneapolis, Minnesota, United States

Seattle, Washington, United States

Chicago, Illinois, United States

Spokane, Washington, United States

Boise, Idaho, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported