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Behavioral Intervention

PAP + Motivational Enhancement for Obstructive Sleep Apnea (Champion Trial)

N/A

Recruiting

Led By Naresh Punjabi

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

≥ 18 years of age

Moderate-to-severe OSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Champion Trial Summary

This trial will compare two treatments for sleep apnea: usual care vs. therapy delivered by culturally-caring health workers. Results will measure adherence to PAP therapy.

Who is the study for?

This trial is for adults over 18 with untreated moderate-to-severe obstructive sleep apnea who can attend study visits and have phone access. It's not for those with a history of OSA surgery, current PAP therapy users, commercial drivers, oxygen users during wakefulness or sleep, recent sleepy driving incidents, unstable medical conditions like uncontrolled heart issues or severe lung disease, active major psychiatric diseases, other sleep disorders, very low awake oxygen levels, insomnia sufferers or participants in another clinical trial.Check my eligibility

What is being tested?

The study aims to see if motivational talks by community health workers help people stick to using their Positive Airway Pressure (PAP) machines compared to the usual care given to patients with obstructive sleep apnea. Participants will either receive this new approach or continue with standard treatment.See study design

What are the potential side effects?

While the side effects are not detailed here since they relate more to the intervention method than a medication per se; generally speaking PAP therapy may cause discomfort such as nasal congestion or dryness but these are typically mild.

Champion Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

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I have moderate-to-severe sleep apnea.

Champion Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Number of hours patient adhered to PAP therapy

Secondary outcome measures

Blood pressure

Epworth Sleepiness Scale Score

Mean Glucose Level

Champion Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Motivational Enhancement Therapy (MET)Experimental Treatment2 Interventions

Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.

Group II: PAP therapyActive Control1 Intervention

Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Motivational Enhancement Therapy

2018

Completed Phase 2

~5050

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,978 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,261 Total Patients Enrolled

Naresh PunjabiPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

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

Is this trial open to those above the age of forty?

"Participants must be of age 18 or higher, and not exceed 100 years."

Answered by AI

What criteria must be met to join this research project?

"Eligibility for this medical research requires that participants suffer from obstructive sleep apnea and have reached the age of consent, with an upper limit of 100 years. The goal is to recruit 80 total patients."

Answered by AI

Is it possible to register for this medical research project presently?

"From what is hosted on clinicaltrials.gov, this medical research endeavour does not have any open spots for prospective participants at present time. This trial was initially posted on December 15th 2023 and last edited September 14th 2023; however, 231 other studies are actively recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Naresh Punjabi 2023. "Community Health Advocates for Motivating PAP Use in Our Neighborhoods.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047353.