Do Endotypes Predict Response and Sequelae in OSA Patients

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04875364
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea
  • Sleep
  • Sleep Apnea
  • Sleep Apnea, Obstructive
  • Sleep Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Eszopiclone — DRUG
    2mg of Eszopiclone just before going to sleep.
  • Supplemental Oxygen — OTHER
    Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.
  • Continuous Positive Airway Pressure (CPAP) — DEVICE
    A standard CPAP device will be provided using the settings as prescribed by the treating physician.

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
Sep 2024
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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).

Primary Outcome Measure

Psychomotor Vigilance Test [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altman Clinical and Translational Research Institute BuildingLa JollaCalifornia92037
Pamela DeYoung
[email protected]
8582462154
Dillon Gilbertson, MS
[email protected]
8582462154
Christopher Schmickl

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By research site
Altman Clinical and Translational Research Institute Building· La Jolla, CA

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