Active — Not RecruitingPhase 2

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

United States60 participantsStarted 2025-04-02

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. At minimum of 25% central or mixed apneas (as proportion of total apneas) with a minimum of 2.5 central or mixed apneas/hour of sleep
✓. OR evidence of clear Cheyne-Stokes breathing pattern during the baseline PSG (regardless of central apnea component).
✓. OR evidence of OSA with LGn \>0.5 at the baseline PSG (regardless of central apnea component) Average SpO2 during sleep ≥88%

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.

Timeframe: up to 6 weeks

Trial details

NCT IDNCT06776432

SponsorShionogi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Sleep Apnea trials