Acetazolamide on REM OSA
OSA is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness and quality of life. In particular, REM sleep is accompanied by more frequent and longer obstructive events, that yield more profound hypoxemia than during non-REM (nREM). Exaggerated OSA severity in REM is the consequence of ventilatory drive dips, particularly during phasic eye movements. Unfortunately, the leading treatment for REM and nREM OSA, CPAP-which acts to pneumatically splint the pharynx open-is intolerable for many patients. Treatment outcomes for REM OSA are burdened by further incomplete CPAP adherence later in the night, which commonly leaves REM periods undertreated. In this protocol, the investigators will test the effect of Acetazolamide on REM OSA and on ventilatory parameters such as genioglossus muscle activity and ventilatory drive.
Conditions:
🦠 Obstructive Sleep Apnea
🗓️ Study Start (Actual) 30 January 2023
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Diagnosed REM OSA (per baseline screening: REM AHI/nREM AHI≥2) \[31-33\]
    • * REM duration\>10 minutes
    • * Not using CPAP (\>1 week).

    Exclusion Criteria:

    • * Any uncontrolled medical condition
    • * Current use of the medications under investigation
    • * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
    • * Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
    • * Respiratory disorders other than sleep disordered breathing:
    • chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
    • * Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
    • * Contraindications for acetazolamide, including:
    • * Hyperchloremic acidosis
    • * Hypokalemia
    • * Hyponatremia
    • * Adrenal insufficiency
    • * Impaired kidney function
    • * Hypersensitivity to acetazolamide or other sulfonamides.
    • * Marked liver disease or impairment of liver function, including cirrhosis.
    • * Contraindications to the use of lidocaine 4%/oxymetazoline HCT.
    • * Claustrophobia
    • * Pregnancy or nursing
Ages Eligible for Study: 21 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 18 October 2022
  • First Submitted that Met QC Criteria 18 October 2022
  • First Posted 21 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 January 2024
  • Last Update Posted 11 January 2024
  • Last Verified January 2024