Status:
RECRUITING
Do Endotypes Predict Response and Sequelae in OSA Patients
Lead Sponsor:
University of California, San Diego
Conditions:
Obstructive Sleep Apnea
Sleep Apnea
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04875364
Start Date
August 1 2020
End Date
January 1 2027
Last Update
October 2 2024
Active Locations (1)
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1
Altman Clinical and Translational Research Institute Building
La Jolla, California, United States, 92037