Clinical trial NCT04875364: Do Endotypes Predict Response and Sequelae in OSA Patients
Official title: Do Endotypes Predict Response and Sequelae in OSA Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Sleep Apnea, Obstructive
Sleep
Sleep Disorder
Keywords: sleep
sleep apnea
OSA
obstructive sleep apnea
lunesta
cpap
endotype
Eszopiclone
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Psychomotor Vigilance Test
timeFrame: 8 weeks
measure: Endothelial Dysfunction
timeFrame: 8 weeks
Secondary outcomes:
measure: Neurocognitive Assessment: NIH Toolbox
timeFrame: 8 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 8 weeks
measure: Richard's Campbell Sleep Questionnaire (RCSQ)
timeFrame: 8 weeks
measure: Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
timeFrame: 8 weeks
measure: Beck Depression Index-II
timeFrame: 8 weeks
measure: SF-36 Item Health Survey (SF-36)
timeFrame: 8 weeks
measure: Brief Pain Inventory (Short Form)
timeFrame: 8 weeks
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity
timeFrame: 8 weeks
measure: Systolic Blood Pressure
timeFrame: 8 weeks
measure: Diastolic Blood Pressure
timeFrame: 8 weeks
measure: Patient's Assessment of Own Function Inventory (PAOF) questionnaire
timeFrame: 8 weeks
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) pain interference
timeFrame: 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute Building
state: California
Study officials:
affiliation: Professor, Medicine
name: Atul Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postdoc Fellow, Medicine
name: Christopher Schmickl
role: PRINCIPAL_INVESTIGATOR
References: