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Do Endotypes Predict Response and Sequelae in OSA Patients

NCT04875364 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-02

No results posted yet for this study

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

Interventions

DRUG

Eszopiclone

2mg of Eszopiclone just before going to sleep.

OTHER

Supplemental Oxygen

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

DEVICE

Continuous Positive Airway Pressure (CPAP)

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

Sponsors & Collaborators

Principal Investigators

  • Atul Malhotra, MD · Professor, Medicine

  • Christopher Schmickl · Postdoc Fellow, Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875364 on ClinicalTrials.gov