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Sivopixant + Acetazolamide + SASS-001 for Sleep Apnea
Brandon, FL
Phase 2
Recruiting
Research Sponsored by Shionogi Apnimed Sleep Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
History of obesity-hypoventilation syndrome or respiratory disturbance due to opioids
Narcolepsy, restless leg syndrome requiring medication, REM sleep behavior disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
"This trial aims to see how well sivopixant, acetazolamide, and SASS-001 work in adults with sleep apnea that has a central component."
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Who is the study for?
Adults with sleep apnea, specifically those who have stopped or are non-compliant with PAP therapy, can join this trial. Participants should not be using any OSA devices for at least a week before the study and must have certain levels of oxygen desaturation and apnea-hypopnea index. Pregnant women, individuals with severe heart issues, uncontrolled psychiatric disorders, recent serious illnesses or infections, drug abuse history within 24 months, or on certain medications cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness of three treatments: Sivopixant (a new medication), Acetazolamide (an existing diuretic), and SASS-001 against a placebo in adults with sleep apnea that includes central breathing interruptions during sleep.See study design
What are the potential side effects?
Possible side effects may include tingling sensations (paresthesia), drowsiness, confusion from acetazolamide; fatigue or headache from sivopixant; and general discomfort or reactions to placebos. Each person's reaction to the medication can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average oxygen levels drop frequently but not extremely low during sleep.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had breathing problems due to obesity or opioid use.
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I have narcolepsy, restless leg syndrome needing medication, or REM sleep behavior disorder.
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I have had severe heart rhythm problems without a defibrillator.
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I have bronchiectasis and my asthma is not under control.
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I am not pregnant or nursing.
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I have trouble breathing even when resting.
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I have never used chronic oxygen therapy.
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My oxygen levels drop below 93% when awake or below 88% when asleep.
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My liver and kidney functions are not within the normal range.
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My heart failure is mainly due to a valve issue, after childbirth, or inflammation.
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I have adrenal gland failure.
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I am not taking any medications that are not allowed in the study.
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I have had a stroke in the past.
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I have severe COPD with less than half the normal lung function.
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I have significant issues with my upper airway or jaw development.
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I am not taking excluded medications like Digoxin, opioids, or high-dose Aspirin.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Part B I: AcetazolamideActive Control1 Intervention
After completing Part A, participants will receive acetazolamide oral tablets once daily at bedtime for 3 days.
Group II: Part B II: SASS-001Active Control1 Intervention
After completing Part B I, participants will receive SASS-001 oral tablets once daily at bedtime for 10 days.
Group III: Part A: SivopixantActive Control1 Intervention
Participants will receive sivopixant oral tablets once daily at bedtime for 17 days.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo to match the study drug during the 17 days of Part A followed by 13 days of Part B.
Find a Location
Closest Location:Intrepid Research, LLC· Cincinnati, OH· 100 miles
Who is running the clinical trial?
Shionogi Apnimed Sleep ScienceLead Sponsor
Chief Scientific OfficerStudy DirectorShionogi Apnimed Sleep Science
11 Previous Clinical Trials
2,686 Total Patients Enrolled