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Study of Sivopixant, Acetazolamide, and SASS-001 for Sleep Apnea

This study is testing three different medications – sivopixant, acetazolamide, and SASS-001 – to see how safe and effective they are for adults with sleep apnea that has a central component (meaning the brain doesn't send proper signals to breathe). You might be able to join if you are between 18 and 85 years old and have certain heart conditions like stable heart failure or heart failure with preserved ejection fraction and high blood pressure. The main goal is to see if these medications can reduce the number of times breathing stops or becomes very shallow during sleep (called the apnea-hypopnea index) over about 6 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 60 participants. It will compare the effects of sivopixant, acetazolamide, SASS-001, and a placebo (an inactive substance) on sleep apnea.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at up to 6 weeks, which suggests participants will be followed for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06776432

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

Active, Not Recruiting
PHASE2Ages 18–85InterventionalTreatment
Shionogi
~60 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:SivopixantPlaceboAcetazolamideSASS-001

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint - Change in apnea-hypopnea index (SASS-001 arm vs baseline at Visit 7 polysomnography). Scale is minimum -60 to max 60. Lower scores mean improvement from baseline.
Measured over up to 6 weeks

Conditions

Sleep Apnea

Explore related trials

Central Sleep ApneaObstructive Sleep ApneaSleep Apnea

Where it's being run

9 sites across 8 states
Florida2
California1
Massachusetts1
Michigan1
Minnesota1
Ohio1
South Carolina1
Texas1

Study leadership

  • Chief Scientific Officer · STUDY_DIRECTOR · Apnimed

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Stable heart failure with reduced ejection fraction (NYHA class 1-3 inclusive) with or without atrial fibrillation
Heart failure with preserved ejection fraction (NYHA class 1-3 inclusive) and hypertension (BP\>120/80 mmHg at screening visit despite the treatment with ≥2 antihypertensives) with or without atrial fibrillation
Persistent atrial fibrillation (continuous and sustained for more than 7 days, rate controlled with resting HR\<100bpm)1 without heart failure
History of primary (essential) hypertension with BP at screening visit \>130/80 mmHg despite the treatment with \>2 antihypertensives
Evidence of complex sleep apnea (CPAP-emergent central sleep apnea with documented CAI\>5 events/h on CPAP within 1 year from screening)

What this trial measures

  • Primary Endpoint - Change in apnea-hypopnea index (SASS-001 arm vs baseline at Visit 7 polysomnography). Scale is minimum -60 to max 60. Lower scores mean improvement from baseline.up to 6 weeks