NCT04875364 Do Endotypes Predict Response and Sequelae in OSA Patients
| NCT ID | NCT04875364 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-08-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2020-08-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Atul Malhotra, MD
PRINCIPAL INVESTIGATOR
Professor, Medicine
Frequently Asked Questions
Who can join the NCT04875364 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04875364 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04875364 currently recruiting?
Yes, NCT04875364 is actively recruiting participants. Contact the research team at pdeyoung@health.ucsd.edu for enrollment information.
Where is the NCT04875364 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT04875364 clinical trial?
NCT04875364 is sponsored by University of California, San Diego. The principal investigator is Atul Malhotra, MD at Professor, Medicine. The trial plans to enroll 200 participants.