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Positive Airway Pressure Device

CPAP for Sleep Apnea in Opioid Users (PRESTO Trial)

Phase 2
Recruiting
Led By Jeremy Orr, 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 8 weeks
Awards & highlights

PRESTO Trial Summary

This trial will study whether people with chronic pain who use opioids and have sleep disordered breathing might benefit from using a device that provides continuous positive airway pressure during sleep.

Who is the study for?
This trial is for adults over 18 with chronic pain who regularly use opioids and have sleep disordered breathing (SDB). They must not be current CPAP users, pregnant, prisoners, or using opioids recreationally. People with severe psychiatric conditions other than treated mood disorders or those unable to follow the study procedures are also excluded.Check my eligibility
What is being tested?
The study tests if continuous positive airway pressure (CPAP) improves sleep quality, pain management, and overall life quality in patients with SDB due to chronic opioid use. It will also assess adherence to CPAP treatment and identify predictors of its effectiveness.See study design
What are the potential side effects?
While CPAP is generally safe, side effects can include discomfort wearing the mask, dry nose or throat, nasal congestion, headaches or ear pressure. Some may experience claustrophobia from the mask.

PRESTO 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
PROMIS sleep disturbance
Secondary outcome measures
Brief pain inventory
Other outcome measures
Apnea Hypopnea Index
Beck Depression Inventory
Cold Pressor Test
+8 more

PRESTO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CPAPExperimental Treatment1 Intervention
Use of CPAP, a device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks.
Group II: ControlActive Control1 Intervention
No CPAP use, otherwise usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positive Airway Pressure (PAP)
2016
N/A
~240

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,363 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,532 Total Patients Enrolled
Jeremy Orr, MDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Positive Airway Pressure (PAP) (Positive Airway Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT04928157 — Phase 2
Obstructive Sleep Apnea Research Study Groups: Control, CPAP
Obstructive Sleep Apnea Clinical Trial 2023: Positive Airway Pressure (PAP) Highlights & Side Effects. Trial Name: NCT04928157 — Phase 2
Positive Airway Pressure (PAP) (Positive Airway Pressure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04928157 — Phase 2
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04928157 — Phase 2

Frequently Asked Questions

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

Are there any patients currently enrolled in this trial?

"The study is still recruiting patients, according to the most recent information available on clinicaltrials.gov. This particular trial was first announced on August 10th, 2021 and received its last update on June 27th, 2022."

Answered by AI

What are the safety risks associated with Positive Airway Pressure (PAP) therapy?

"PAP is a Phase 2 trial, which means there is data supporting safety but not efficacy. Therefore, our team at Power gave it a score of 2."

Answered by AI

How many people are being given this experimental treatment?

"That is accurate. The clinicaltrial.gov website has the study's most recent information, which includes an edit from June 27th, 2022. This particular trial is looking for 62 individuals at a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have sleep apnea and do not like using my CPAP machine, But if I don't, I'm exhausted all day and have bad headaches, I never has sleep apnea until my physician started my on Buprenorphine (Butrans) for pain.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of California San Diego: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
Jeremy Orr, M.D. 2021. "Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04928157.
All > Sleep Disorders > Pain
~0 spots leftby May 2024
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