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Oxygen for Obstructive Sleep Apnea (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

CRESCENDO-SLP Trial 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.Check my eligibility

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.See study design

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.

CRESCENDO-SLP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

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

Primary outcome measures

5th generation troponin

MiR-210

Reactive Hyperemia Index

+1 more

Secondary outcome measures

Response Speed

Verbal Paired-Associates task

CRESCENDO-SLP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,804 Total Patients Enrolled

Atul Malhotra, MDPrincipal InvestigatorUCSD

11 Previous Clinical Trials

665 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants who are being recruited for this research study?

"Affirmative. Information on clinicaltrials.gov indicates that this research endeavor is currently in the recruitment phase. The trial was initially made public on February 13th, 2024 and saw its latest update on February 29th, 2024. A total of 240 participants are sought from a single site for inclusion in the study."

Answered by AI

What are the potential risks associated with administering oxygen to patients?

"The safety rating for Oxygen is a 2, as per our assessment at Power. This Phase 2 trial indicates some existing safety data but lacks evidence regarding efficacy."

Answered by AI

Does this research project accept participants older than 25 years of age?

"Individuals aged between 40 and 79 are eligible to participate in this research study. Notably, there is a substantial pool of studies available for participants under 18 years old (448 studies) as well as those over 65 years old (1710 studies)."

Answered by AI

Are new patients currently being enrolled in this research study?

"The trial, currently seeking participants, was initially listed on clinicaltrials.gov on February 13th, 2024 and last revised on February 29th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

Atul Malhotra 2024. "The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05237505.

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