RECRUITING

Do Endotypes Predict Response and Sequelae in OSA Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Do Endotypes Predict Response and Sequelae in OSA Patients

Quick Facts

Study Start:2020-08-01
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04875364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 21-65 years old
  2. * Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - \* see below)
  3. * BMI 20 - 35 kg/m2
  1. * Pregnancy (current or planned)
  2. * Nursing
  3. * Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
  4. * Already on effective therapy and adherent to treatment for OSA
  5. * Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
  6. * Circadian rhythm disorder
  7. * Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
  8. * Uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>95)
  9. * Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
  10. * Presence of tracheostomy
  11. * Hospitalization within the past 90 days
  12. * Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\< 5 years)
  13. * Prior gastric bypass surgery
  14. * Chronic liver disease or end-stage kidney disease
  15. * Active cancer
  16. * Allergy to any of the study drug
  17. * Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
  18. * Chronically using study drug (Eszopiclone)
  19. * Active illicit substance use
  20. * Alcohol use of \>1 standard drink/night for women or \>2 standard drinks/night for men nightly alcohol use
  21. * Active smoking or vaping within the past 6 months
  22. * Psychiatric disease, other than controlled depression/anxiety
  23. * Prisoners
  24. * Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.

Contacts and Locations

Study Contact

Pamela DeYoung
CONTACT
8582462154
pdeyoung@health.ucsd.edu

Principal Investigator

Atul Malhotra, MD
PRINCIPAL_INVESTIGATOR
Professor, Medicine
Christopher Schmickl
PRINCIPAL_INVESTIGATOR
Postdoc Fellow, Medicine

Study Locations (Sites)

Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Atul Malhotra, MD, PRINCIPAL_INVESTIGATOR, Professor, Medicine
  • Christopher Schmickl, PRINCIPAL_INVESTIGATOR, Postdoc Fellow, Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-01
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2020-08-01
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • sleep
  • sleep apnea
  • OSA
  • obstructive sleep apnea
  • lunesta
  • cpap
  • endotype
  • Eszopiclone

Additional Relevant MeSH Terms

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