Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea

Overview

About this study

The purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • OSA measures
  • Average oxygen desaturation index 4 (ODI4) ≥ 7 and < 55 events/h and average SpO2≥88% during sleep from continuous home pulse oximetry recordings at screening
  • AHI4 of > 10 to <60 events/h
  • Patients currently using PAP will be eligible for inclusion in the study if:
  • Non-compliant to CPAP (less than 4 hr/night for 5 days/week) and they express willingness to discontinue treatment for a minimum of 7 days before the baseline SpO2 assessments
  • Patients who discontinued PAP
  • Naïve to PAP

Exclusion Criteria:

  • Sustained SpO2<93% during wakefulness or mean SpO2<88% during sleep, calculated from PSG at screening
  • Dyspnea at rest or patients with heart failure class IV NYHA
  • Blood pressure <90/50 mmHg or >160/100 mmHg at V1
  • Recent (<3 months) episode of acute myocardial infarction or acute decompensated heart failure
  • History of stroke
  • History of sustained ventricular tachyarrhythmias or other severe arrhythmias without defibrillator implanted
  • Heart failure primarily caused by valvular, post-partum cardiomyopathy or active myocarditis
  • History of obesity-hypoventilation syndrome or respiratory disturbance due to opioids
  • History of bronchiectasis and uncontrolled asthma
  • History of chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted (European Respiratory Society criteria)
  • Started treatment with β-blockers <3 months before the study. Patients not taking β-blockers or taking β-blockers for >3 months can be enrolled.
  • Narcolepsy, restless leg syndrome requiring medication, REM sleep behavior disorder
  • Pronounced anatomical abnormalities of upper airway (adenoid vegetations, grade ≥3 tonsillar hypertrophy, etc.), pronounced micrognathia, or pronounced incomplete development of the lower jaw
  • History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) or International Classification of Disease tenth edition criteria
  • Medically unexplained positive screen for drugs of abuse (excluding THC/marijuana) or history of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit
  • A significant illness or infection requiring medical treatment in the past 30 days as determined by investigator
  • Clinically significant cognitive dysfunction as determined by investigator.
  • Women who are pregnant or nursing
  • Participants with reduced sodium and/or potassium blood serum levels
  • Participants with suprarenal gland failure
  • Participants with hyperchloremic acidosis
  • Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 1 week prior to first PSG and are not used during participation in the study (through V7). Patients that are non-compliant to CPAP (less than 4hr/night for 5 days/week) can be enrolled, as well as patients who are naïve to PAP and patients who discontinued PAP previously. PAP compliant patients cannot be enrolled.
  • History of chronic oxygen therapy are excluded
  • Concomitant use of medications from the list of disallowed medications
  • Hepatic transaminases >2X the upper limit of normal (ULN), total bilirubin >1.5X ULN (unless confirmed Gilbert syndrome), estimated glomerular filtration rate <40 ml/min
  • Excluded Medications
  • Digoxin, methyldigoxin, beta-methyldigoxin.
  • Opioids
  • Mecamylamine
  • Methenamine
  • Sodium Phosphates
  • Chronic use of more than 500 mg/day of Aspirin
  • GLP1 receptor agonists for weight loss, unless reached stable dose and stable weight (<4lbs weight change per month) for 3+ months
  • Other carbonic anhydrase inhibitors (zonisamide, topiramate, etc)
  • Lithium

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/03/2025. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Peter Gay, M.D.

Contact us for the latest status

Contact information:

Rebecca Ra

(507) 284-2122

Ra.Rebecca@mayo.edu

More information

Publications

Publications are currently not available