Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT05589792
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed REM OSA (per baseline screening: REM AHI/nREM AHIā„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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT05589792
Study Brief:
Protocol Section:
NCT05589792