Status:
RECRUITING
Managing Opioid Related Sleep Apnea With Acetazolamide
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep-Disordered Breathing
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Patients who use chronic opioids for chronic pain daily for \>3 months will be recruited. The investigators will study patients with established sleep disordered breathing (SDB; defined as an apnea-hy...
Eligibility Criteria
Inclusion
- Age 18+
- Chronic pain
- Chronic opioid use (daily use for \>3 months duration) with \>/= 20 oral Morphine Equivalent Dose (MEqD) per day
- Apnea-hypopnea index \>/= 10 events/hr (hypopnea definition: ≥ 3% desaturation or arousal criteria per American Academy of Sleep Medicine 2012 scoring rules)
Exclusion
- Use of opioids outside medical supervision (e.g. recreational use)
- Unable or unwilling to withhold any ongoing SDB treatment (e.g. CPAP) for the duration of the study
- Urgent need to initiate effective SDB therapy
- Chronic lung disease (other than well-controlled asthma)
- Active cardiac disease including heart failure, chest pain, or heart rhythm problems
- Neurological or developmental problems affecting breathing
- Major sleep disorders other than sleep apnea
- Chronic kidney disease
- Cirrhosis of the liver
- Active cancer treatment or limited life expectancy
- Psychiatric disease other than controlled mood disorders
- Use of diuretics, potassium supplementation, or medications that may affect potassium
- Allergy to study drug or related compounds including sulfa drugs
- Know electrolyte disturbances
- Hospitalized in the last 90 days or anticipated hospitalization within 3 months
- Alcohol use \>2 standard drinks per day
- Presence of tracheostomy or artificial airway
- Prisoners
- Pregnancy or anticipating pregnancy in next 2 months, or nursing
- Unable or unwilling to provide informed consent
- Unable to follow study protocol
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06043830
Start Date
October 18 2023
End Date
September 1 2025
Last Update
April 24 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92037