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NCT06776432RECRUITINGIRB Ready

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

Sponsored by Shionogi Apnimed Sleep Science

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 60 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

Inclusion Criteria

To enroll, subjects need to have a previous diagnosis of at least one or more of the following comorbidities:
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 โ‰ฅ2 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) Standard care for heart failure and atrial fibrillation for at least 3 weeks before the screening visit OSA measure

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

60 participants

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Age Range

18 Years - 85 Years

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Gender

ALL

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Sponsor

Shionogi Apnimed Sleep Science

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Brandon

Florida

Location available
View Brandon location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

North Dartmouth

Massachusetts

Location available
View North Dartmouth location page
RECRUITING

Detroit

Michigan

Location available
View Detroit location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page
RECRUITING

Rock Hill

South Carolina

Location available
View Rock Hill location page
RECRUITING

Huntsville

Texas

Location available
View Huntsville location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Sleep Apnea Treatment in La Jolla?

Join others in California exploring innovative treatment options through clinical research

Sleep Apnea Treatment Options in La Jolla, California

If you're searching for Sleep Apnea treatment in La Jolla, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in La Jolla, Brandon, Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Sleep Apnea. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sleep Apnea?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Sleep Apnea

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Sleep Apnea Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06776432. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.