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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

ExPRESSION Trial 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.Check my eligibility
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.See study design
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.

ExPRESSION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 65 years old.

ExPRESSION Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial Dysfunction
Psychomotor Vigilance Test
Secondary outcome measures
Beck Depression Index-II
Brief Pain Inventory (Short Form)
Diastolic Blood Pressure
+11 more

ExPRESSION 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
Continuous Positive Airway Pressure (CPAP)
2004
Completed Phase 3
~2880
Eszopiclone
2005
Completed Phase 4
~4200

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,225 Total Patients Enrolled
Christopher SchmicklPrincipal InvestigatorPostdoc Fellow, Medicine
Atul Malhotra, MDPrincipal InvestigatorProfessor, Medicine
11 Previous Clinical Trials
705 Total Patients Enrolled

Media Library

Continuous Positive Airway Pressure (CPAP) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04875364 — Phase 2
Obstructive Sleep Apnea Research Study Groups: Usual PAP Start, Early PAP Start
Obstructive Sleep Apnea Clinical Trial 2023: Continuous Positive Airway Pressure (CPAP) Highlights & Side Effects. Trial Name: NCT04875364 — Phase 2
Continuous Positive Airway Pressure (CPAP) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875364 — Phase 2
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04875364 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned Supplementary Oxygen for medical use?

"The safety of Supplemental Oxygen is rated as a 2, since this Phase 2 trial has some evidence suggesting its security but none affirming efficacy."

Answered by AI

What are the fundamental aims of this medical experiment?

"Over an 8 week period, principal objectives of this trial are measured using the Psychomotor Vigilance Test. Secondary assessment criteria include Diastolic and Systolic Blood Pressure which is recorded following accepted standards as well as Neurocognitive Assessment: NIH Toolbox, which produces a general cognitive function score in addition to two scores for crystallized cognition (Oral Reading Recognition and Picture Vocabulary) and five scores for fluid cognition (Picture Sequence Memory Task, Dimensional Change Card Sort Task, Pattern Comparison Task, Flanker Inhibitory Control & Attention Task, List Sorting Task)."

Answered by AI

Are new participants being enrolled for this experiment?

"As per the information on clinicaltrials.gov, this trial is presently open for enrolment. The study was first advertised on August 1st 2020 and has had its details refreshed as recently as July 26th 2022."

Answered by AI

Does this clinical trial encompass individuals of all ages, or is there an age limit?

"This trial has specified that potential participants must be between the ages 21 to 65. For those under 18 and over 65, there are 100 studies respectively available for them."

Answered by AI

What supplementary investigations have been conducted around the use of Supplemental Oxygen?

"Currently, there are 4 ongoing studies on Supplemental Oxygen with one of them in its final Phase 3. The bulk of these investigations take place in Salt Lake City, UT yet 39 other sites across the country are also involved in this research endeavor."

Answered by AI

How many participants is this trial accepting at its peak?

"Affirmative. According to records on clinicaltrials.gov, this research study is actively seeking participants and was initially posted on August 1st 2020. 200 candidates are sought from a single site for the trial's completion."

Answered by AI

Who meets the eligibility criteria for participation in this clinical trial?

"To be accepted into this medical trial, potential participants must suffer from obstructive sleep apnea and fall within the age bracket of 21 to 65. The study is currently trying to recruit 200 individuals."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
California
What site did they apply to?
Altman Clinical and Translational Research Institute Building
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Low blood oxygen during sleep. I have had sleep apnea for about 6 years and I'm seeking a new treatment other that a CPAP machine. I strongly dislike wearing it.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How often are in person screening visits?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Do Endotypes Predict Response and Sequelae in OSA Patients
Atul Malhotra 2020. "Do Endotypes Predict Response and Sequelae in OSA Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875364.
All > Sleep Disorders > Sleep
~83 spots leftby Jan 2027
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