CompletedPhase 2

Do Endotypes Predict Response and Sequelae in OSA Patients

United States233 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ni…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial studied whether different 'endotypes' — meaning underlying biological causes — of sleep apnea predict how well patients respond to treatment, so could my doctor test to find out which endotype of OSA I might have and whether that changes what treatment is recommended for me?
2The trial measured Psychomotor Vigilance Test performance, which tracks alertness and reaction time — how impaired is my vigilance right now, and is that something my doctor would want to formally measure before deciding on my treatment plan?
3Since this was a Phase 2 study that has already completed, has my doctor seen any results or publications from it that might inform whether my specific type of OSA is more or less likely to respond to a particular therapy?
4The trial also looked at endothelial dysfunction, which relates to blood vessel health — does my doctor think my OSA may already be affecting my cardiovascular system, and should that factor into how urgently we start treatment?
5Because this study is completed rather than actively enrolling, are there any follow-up trials or studies building on these findings that my doctor thinks might be worth considering as an option alongside or instead of standard treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychomotor Vigilance Test

Timeframe: 8 weeks

Endothelial Dysfunction

Timeframe: 8 weeks

Trial details

NCT IDNCT04875364

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-11

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials