Do Endotypes Predict Response and Sequelae in OSA Patients (ExPRESSION)

University of California San Diego

Status and phase: Enrolling; Phase 2

Conditions: Sleep Disorder; Sleep Apnea, Obstructive; Sleep Apnea; Sleep; Obstructive Sleep Apnea

Treatments: Other: Supplemental Oxygen; Device: Continuous Positive Airway Pressure (CPAP); Drug: Eszopiclone

Study type: Interventional

Funder types: Other

Identifiers

NCT04875364

201432

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early PAP Start

Experimental group

Description:

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.

Treatment:

Drug: Eszopiclone

Device: Continuous Positive Airway Pressure (CPAP)

Other: Supplemental Oxygen

Usual PAP Start

Experimental group

Description:

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).

Treatment:

Drug: Eszopiclone

Other: Supplemental Oxygen