Summary

Eligibility
for people ages 21-65 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Atul Malhotra
Photo of Atul Malhotra
Atul Malhotra

Description

Summary

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.

Keywords

Obstructive Sleep Apnea Sleep Apnea Sleep Apnea, Obstructive Sleep Sleep Disorder OSA lunesta cpap endotype Eszopiclone Apnea Sleep Apnea Syndromes Sleep Wake Disorders Supplemental Oxygen Continuous Positive Airway Pressure (CPAP) Early PAP Start

Eligibility

You can join if…

Open to people ages 21-65

  • Ages 21-65 years old
  • Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - * see below)
  • BMI 20 - 35 kg/m2

You CAN'T join if...

  • Pregnancy (current or planned)
  • Nursing
  • Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
  • Already on effective therapy and adherent to treatment for OSA
  • Other known untreated sleep fragmenting disorder, such as 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 blood pressure >160, diastolic blood pressure >95)
  • Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
  • Presence of tracheostomy
  • Hospitalization within the past 90 days
  • Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (< 5 years)
  • Prior gastric bypass surgery
  • Chronic liver disease or end-stage kidney disease
  • Active cancer
  • Allergy to any of the study drug
  • Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
  • Chronically using study drug (Eszopiclone)
  • Active illicit substance use
  • Alcohol use of >1 standard drink/night for women or >2 standard drinks/night for men nightly alcohol use
  • Active smoking or vaping within the past 6 months
  • Psychiatric disease, other than controlled depression/anxiety
  • Prisoners
  • Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.

Location

  • Altman Clinical and Translational Research Institute Building
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Atul Malhotra
    Professor, Medicine. Authored (or co-authored) 541 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04875364
Phase
Phase 2
Study Type
Interventional
Last Updated