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Device

CPAP + Medication + Oxygen for Obstructive Sleep Apnea (ExPRESSION Trial)

Phase 2

Recruiting

Led By Christopher Schmickl

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

Ages 21-65 years old

Be older than 18 years old

Must not have

Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy

Already on effective therapy and adherent to treatment for OSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study people with Obstructive Sleep Apnea to try and understand why some people have it and how it affects them.

Who is the study for?

This trial is for men and women aged 21-65 with a physician's diagnosis of OSA, or suspected to have it, who are not active smokers/vapers and do not have uncontrolled high blood pressure, chronic lung disease requiring oxygen, recent hospitalization, heavy alcohol use, certain heart conditions, active cancer or other specific health issues. BMI must be between 20 - 35 kg/m2.

What is being tested?

The study aims to understand why people develop Obstructive Sleep Apnea (OSA) and how this relates to the effectiveness of treatments like CPAP machines, eszopiclone medication for sleep aid, and supplemental oxygen therapy in managing symptoms such as sleepiness and high blood pressure.

What are the potential side effects?

Possible side effects may include discomfort from wearing the CPAP device at night; dizziness, dry mouth or unpleasant taste from eszopiclone; and dry nasal passages from using supplemental oxygen.

Eligibility Criteria

Inclusion Criteria

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

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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been treated for any sleep disorders like narcolepsy.

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I am following my treatment plan for sleep apnea.

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I have been regularly taking Eszopiclone.

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I can give my own consent and complete English-only study tasks.

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I need extra oxygen or have high CO2 levels due to lung blockage.

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I have had gastric bypass surgery.

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I was hospitalized in the last 3 months.

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I consume more than the recommended amount of alcohol nightly.

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I have heart issues like untreated blocked arteries, chest pain, past heart attack or stroke, or heart failure.

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My cancer is currently active.

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I have had a stomach ulcer, esophageal varices, or bleeding in my digestive tract in the last 5 years.

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I am allergic to the medication used in this study.

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I have chronic liver or severe kidney disease.

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I regularly take medications that can affect my breathing.

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I have a psychiatric condition other than well-managed depression or anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endothelial Dysfunction

Psychomotor Vigilance Test

Secondary study objectives

Beck Depression Index-II

Brief Pain Inventory (Short Form)

Diastolic Blood Pressure

+11 more

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: Usual PAP StartExperimental Treatment2 Interventions

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).

Group II: Early PAP StartExperimental Treatment3 Interventions

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eszopiclone

2005

Completed Phase 4

~4200

Continuous Positive Airway Pressure (CPAP)

2004

Completed Phase 3

~2880