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Oxygen and Bi-Level Ventilation for Overlap Syndrome (CRESCENDO-SLP Trial)

Phase 2
Recruiting
Led By Atul Malhotra, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate the combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), known as overlap syndrome (OVS), and its impact on

Who is the study for?
This trial is for people with a BMI between 24-32 who have both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), known as Overlap Syndrome. It's not suitable for individuals outside this BMI range.
What is being tested?
The study tests whether using bi-level positive airway pressure at night or just oxygen therapy can improve heart health in those with COPD/OSA Overlap Syndrome, compared to those with only OSA or COPD.
What are the potential side effects?
Possible side effects may include discomfort from wearing the mask, dry nose or mouth, bloating, eye irritation, skin marks from the straps, and rarely lung collapse if air leaks into the space around the lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
5th generation troponin
MiR-210
Reactive Hyperemia Index
+1 more
Secondary study objectives
Response Speed
Verbal Paired-Associates task

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: OxygenExperimental Treatment1 Intervention
OVS subjects will receive treatment with oxygen during night time for 6 months
Group II: Bi-level positive pressure non invasive ventilationExperimental Treatment1 Intervention
OVS subjects will receive treatment with bi-level PAP therapy during night time for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen gas
2021
Completed Phase 3
~11330

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,501 Total Patients Enrolled
Atul Malhotra, MDPrincipal InvestigatorUCSD
11 Previous Clinical Trials
665 Total Patients Enrolled
~160 spots leftby Aug 2028
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