RECRUITING

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

Conditions

Sleep Apnea obstructive sleep apnea central sleep apnea

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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

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

Official Title

A Phase 2A Double-Blind Randomized, Controlled, Dose Escalation, Parallel- Arm, Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea

Quick Facts

Study Start:2025-04-02

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06776432

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 to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Chief Scientific Officer, MD

CONTACT

6175008880

contact@apnimed.com

Principal Investigator

Chief Scientific Officer

STUDY_DIRECTOR

Shionogi Apnimed Sleep Science

Study Locations (Sites)

Teradan Clinical Trials

Brandon, Florida, 33511

United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida, 33176

United States

Intrepid Research, LLC

Cincinnati, Ohio, 45245

United States

OnSite Clinical Solutions

Rock Hill, South Carolina, 29732

United States

Huntsville Research Institute LLC

Huntsville, Texas, 77340

United States

Collaborators and Investigators

Sponsor: Shionogi Apnimed Sleep Science

Chief Scientific Officer, STUDY_DIRECTOR, Shionogi Apnimed Sleep Science

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 Date2025-04-02

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-04-02

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

sleep apnea
obstructive sleep apnea
central sleep apnea

Additional Relevant MeSH Terms

Sleep Apnea