Do Endotypes Predict Response and Sequelae in OSA Patients

NCT ID: NCT04875364

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2027-01-01

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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Sleep Apnea, Obstructive; Sleep; Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early PAP Start

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.

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

2mg of Eszopiclone just before going to sleep.

Supplemental Oxygen

Intervention Type: OTHER

Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.

Continuous Positive Airway Pressure (CPAP)

Intervention Type: DEVICE

A standard CPAP device will be provided using the settings as prescribed by the treating physician.

Usual PAP Start

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).

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

2mg of Eszopiclone just before going to sleep.

Supplemental Oxygen

Intervention Type: OTHER

Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.

Interventions

Eszopiclone

2mg of Eszopiclone just before going to sleep.

Intervention Type: DRUG

Supplemental Oxygen

Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.

Intervention Type: OTHER

Continuous Positive Airway Pressure (CPAP)

A standard CPAP device will be provided using the settings as prescribed by the treating physician.

Intervention Type: DEVICE

Other Intervention Names

Lunesta

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Atul Malhotra

Professor, Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atul Malhotra, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, Medicine

Christopher Schmickl

Role: PRINCIPAL_INVESTIGATOR

Postdoc Fellow, Medicine

Locations

Altman Clinical and Translational Research Institute Building

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela DeYoung

Role: CONTACT

pdeyoung@health.ucsd.edu

8582462154

Facility Contacts

Pamela DeYoung

Role: primary

pdeyoung@health.ucsd.edu

8582462154

Dillon Gilbertson, MS

Role: backup

dcgilbertson@health.ucsd.edu

8582462154

Christopher Schmickl

Role: backup

Other Identifiers

201432

Identifier Type: -

Identifier Source: org_study_id