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Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)

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Conditions

Obstructive Sleep ApneaOSAContinuous Positive Airway PressureCPAPAdherenceEszopicloneEndotypeArousal Threshold

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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

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA ("endotypes") such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients.

Official Title

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP): a Pilot Trial

Quick Facts

Study Start:2023-08-31
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05951023

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. * Body Mass Index \<32 kg/m\^2
  3. * Physician diagnosis of OSA (AHI ≥ 10) based on a clinical sleep study within the past 2 years (subjects who report a history of sleep apnea but do not have a sleep study report from the past 2 years available will be offered an overnight home sleep apnea test to verify OSA diagnosis)
  4. * AHI\>5/h on the overnight research sleep study #1
  5. * Subject had the opportunity to use CPAP for at least 1 month
  6. * Continuous positive airway pressure (CPAP) data can be queried remotely and shows usage 0.5-4h/night (based on most recent 30 day period)
  7. * Interest to continue trying CPAP
  1. * "SAVE CPAP Side Effect Score" \>3 (1 point for each: dry mouth, nasal symptoms, CPAP pressure intolerance, claustrophobia, noise problems, soreness/skin irritation, mask fit/leak problems)
  2. * Any high-risk features: Epworth sleepiness score ≥18, safety-critical profession (e.g., commercial driver), prior sleep-related car accident, substantial hypoxemia during sleep \[SpO2\<70% for \>5min\] or awake \[SpO2\<92%\]
  3. * Any uncontrolled medical/psychiatric condition, or safety concern based on MD judgment
  4. * Pregnancy/Breastfeeding (current or planned during the next month)
  5. * Inability to complete study procedures, such as questionnaires that are only available/validated in English
  6. * Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
  7. * Unwilling or unable to withhold CPAP during polysomnography
  8. * Presence of tracheostomy
  9. * Hospitalization within the past 90 days
  10. * Allergy to the study drug
  11. * Regular use of opioids, or benzodiazepines
  12. * Chronically using study drug or other hypnotic
  13. * Significant circadian rhythm disorder or sleepwalking as an adult
  14. * Active illicit substance use or \>3 oz nightly alcohol use
  15. * Prisoners
  16. * Cognitive impairment, unable to provide consent, or unable to carry out research procedures
  17. * Safety concern based on MD judgment

Contacts and Locations

Principal Investigator

Christopher N Schmickl, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

UC San Diego; Altman Clinical and Translational Research Institute Building
La Jolla, California, 92121
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Christopher N Schmickl, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

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 Date2023-08-31
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • Obstructive Sleep Apnea
  • OSA
  • Continuous Positive Airway Pressure
  • CPAP
  • Adherence
  • Eszopiclone
  • Endotype
  • Arousal Threshold

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea