Investigating how endotypes affect treatment response in obstructive sleep apnea patients
Do Endotypes Predict Response and Sequelae in OSA Patients
This study is testing how different causes of obstructive sleep apnea affect how well treatments like CPAP, a sleep medication, and oxygen work for patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04875364 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the underlying causes of Obstructive Sleep Apnea (OSA) and how these endotypes relate to the manifestations of the condition, such as excessive sleepiness and high blood pressure. It will evaluate the effectiveness of various therapeutic approaches, including Continuous Positive Airway Pressure (CPAP), eszopiclone, and supplemental oxygen, based on the identified endotypes. By understanding the specific reasons behind an individual's OSA, the study seeks to tailor treatments more effectively and predict potential complications associated with the disorder.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21-65 with a physician diagnosis of obstructive sleep apnea and a BMI between 20 and 35 kg/m2.
Not a fit: Patients who are already on effective therapy for OSA or have other untreated sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with obstructive sleep apnea.
How similar studies have performed: While the approach of investigating endotypes in OSA is relatively novel, similar studies in other conditions have shown promise in tailoring treatments based on underlying causes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
La Jolla, California
- Altman Clinical and Translational Research Institute Building — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Atul Malhotra, MD — Professor, Medicine
- Study coordinator: Pamela DeYoung
- Email: pdeyoung@health.ucsd.edu
- Phone: 8582462154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.