RECRUITING

Managing Opioid Related Sleep Apnea With Acetazolamide

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

Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. However, this device is not effective or tolerated in all individuals. The goal of this study is to examine whether a medication called acetazolamide can improve SDB, as an alternative to CPAP treatment. The investigators will measure the improvement in SDB, as well as any change in symptoms, during a 1 week treatment with acetazolamide compared with 1 week of placebo (sugar pill). This study will help to provide data for longer term studies of treatment for SDB in patients who use opioids.

Official Title

Managing Opioid Related Sleep Apnea With Acetazolamide

Quick Facts

Study Start:2023-10-18
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06043830

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18+
  2. * Chronic pain
  3. * Chronic opioid use (daily use for \>3 months duration) with \>/= 20 oral Morphine Equivalent Dose (MEqD) per day
  4. * Apnea-hypopnea index \>/= 10 events/hr (hypopnea definition: ≥ 3% desaturation or arousal criteria per American Academy of Sleep Medicine 2012 scoring rules)
  1. * Use of opioids outside medical supervision (e.g. recreational use)
  2. * Unable or unwilling to withhold any ongoing SDB treatment (e.g. CPAP) for the duration of the study
  3. * Urgent need to initiate effective SDB therapy
  4. * Chronic lung disease (other than well-controlled asthma)
  5. * Active cardiac disease including heart failure, chest pain, or heart rhythm problems
  6. * Neurological or developmental problems affecting breathing
  7. * Major sleep disorders other than sleep apnea
  8. * Chronic kidney disease
  9. * Cirrhosis of the liver
  10. * Active cancer treatment or limited life expectancy
  11. * Psychiatric disease other than controlled mood disorders
  12. * Use of diuretics, potassium supplementation, or medications that may affect potassium
  13. * Allergy to study drug or related compounds including sulfa drugs
  14. * Know electrolyte disturbances
  15. * Hospitalized in the last 90 days or anticipated hospitalization within 3 months
  16. * Alcohol use \>2 standard drinks per day
  17. * Presence of tracheostomy or artificial airway
  18. * Prisoners
  19. * Pregnancy or anticipating pregnancy in next 2 months, or nursing
  20. * Unable or unwilling to provide informed consent
  21. * Unable to follow study protocol

Contacts and Locations

Study Contact

Jeremy Orr, MD
CONTACT
858-246-2183
sleepresearch@health.ucsd.edu

Principal Investigator

Jeremy Orr, MD
PRINCIPAL_INVESTIGATOR
UC San Diego

Study Locations (Sites)

University of California San Diego
San Diego, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Jeremy Orr, MD, PRINCIPAL_INVESTIGATOR, UC 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 Date2023-10-18
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Sleep apnea
  • Opioid
  • Lung

Additional Relevant MeSH Terms

  • Sleep-Disordered Breathing
  • Obstructive Sleep Apnea
  • Central Sleep Apnea
  • Chronic Pain
  • Opioid Use