Actively Recruiting

Phase 2
Age: 21Years - 65Years
All Genders
NCT04875364

Do Endotypes Predict Response and Sequelae in OSA Patients

Led by University of California, San Diego · Updated on 2024-10-02

200

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.

CONDITIONS

Official Title

Do Endotypes Predict Response and Sequelae in OSA Patients

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 21-65 years old
  • Men and women with a physician diagnosis of obstructive sleep apnea or strongly suspected to have sleep apnea
  • Body mass index (BMI) between 20 and 35 kg/m2
Not Eligible

You will not qualify if you...

  • Current or planned pregnancy
  • Nursing
  • Unable to provide self-consent or complete English questionnaires
  • Already on effective therapy and adherent to treatment for OSA
  • Other untreated sleep disorders like periodic limb movement disorder or narcolepsy
  • Circadian rhythm disorder
  • Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
  • Uncontrolled hypertension (systolic >160, diastolic >95)
  • Chronic lung disease requiring supplemental oxygen or with hypercapnia
  • Presence of tracheostomy
  • Hospitalization within the past 90 days
  • Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding within 5 years
  • Prior gastric bypass surgery
  • Chronic liver disease or end-stage kidney disease
  • Active cancer
  • Allergy to any study drug
  • Regular use of breathing-affecting medications (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
  • Chronic use of eszopiclone
  • Active illicit substance use
  • Alcohol use exceeding 1 drink/night for women or 2 drinks/night for men
  • Active smoking or vaping within past 6 months
  • Psychiatric disease other than controlled depression or anxiety
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Altman Clinical and Translational Research Institute Building

La Jolla, California, United States, 92037

Actively Recruiting

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Research Team

P

Pamela DeYoung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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