Do Endotypes Predict Response and Sequelae in OSA Patients

201432

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.

2020-08-01

2027-01-01

2027-01-01

Recruiting

Early phase I

200

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-08-04