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Behavioural Intervention

FOCuSEd Intervention for Obstructive Sleep Apnea (FOCuSEd Trial)

Q: At how many distinct sites is the management of this study taking place?

<p>This clinical trial is running at five sites, such as Jesse Brown VA Medical Center in Chicago, Minneapolis VA Health Care System in Minneapolis, and VA Puget Sound Health Care System in Seattle. Additionally, there are 2 other locations where the trial is being conducted.</p>

Q: Are individuals currently able to apply and participate in this ongoing medical trial?

<p>Per information from clinicaltrials.gov, this specific trial is presently not open for participant enrollment. It was first listed on 5/1/2024 and last revised on 4/25/2024. Despite its current inactivity, there are nearly a thousand alternative trials actively seeking participants at the moment.</p>

N/A

Waitlist Available

Research Sponsored by Seattle Institute for Biomedical and Clinical Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)

COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

FOCuSEd Trial Summary

This trial will test a telehealth program for 400 overweight and obese patients with COPD and OSA. Participants will be split into two groups, one receiving the telehealth intervention and the other receiving

Who is the study for?

This trial is for overweight and obese patients with both COPD (Chronic Obstructive Pulmonary Disease) and OSA (Obstructive Sleep Apnea), receiving care at selected VA medical centers. Participants should be eligible for primary care services, but specific inclusion and exclusion criteria details are not provided.Check my eligibility

What is being tested?

The study tests a telehealth intervention against 'enhanced' usual care in improving quality of life for those with COPD and OSA. The intervention includes a lifestyle program, supervised pulmonary rehab, and potential weight management medications. Usual care prompts referrals to existing programs.See study design

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information. However, as this involves lifestyle changes and exercise interventions rather than medication or invasive procedures, fewer direct side effects may be expected.

FOCuSEd Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with obstructive sleep apnea.

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I have COPD confirmed by a specific lung function test.

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I experience shortness of breath when moving.

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I have smoked the equivalent of 10 packs of cigarettes a year or more.

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I am 40 years old or older.

FOCuSEd Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Health-Related Quality of life

Secondary outcome measures

Cardiovascular risk

Clinical Outcomes

Clinically Significant Weight Loss

+10 more

FOCuSEd Trial Design

2Treatment groups

Active Control

Group I: FOCuSEd InterventionActive Control1 Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.

Group II: Usual Care- EnhancedActive Control1 Intervention

For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor

53 Previous Clinical Trials

13,400 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

552 Previous Clinical Trials

29,997,458 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is the management of this study taking place?

"This clinical trial is running at five sites, such as Jesse Brown VA Medical Center in Chicago, Minneapolis VA Health Care System in Minneapolis, and VA Puget Sound Health Care System in Seattle. Additionally, there are 2 other locations where the trial is being conducted."

Answered by AI

Are individuals currently able to apply and participate in this ongoing medical trial?

"Per information from clinicaltrials.gov, this specific trial is presently not open for participant enrollment. It was first listed on 5/1/2024 and last revised on 4/25/2024. Despite its current inactivity, there are nearly a thousand alternative trials actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06390345.