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Statins + CPAP for Sleep Apnea (SCAT-OSA Trial)

Phase 1 & 2
Waitlist Available
Led By Prachi Singh, Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6months
Awards & highlights

SCAT-OSA Trial Summary

This trial looks at how well statins work in addition to the standard OSA treatment of CPAP in reducing fat tissue.

Who is the study for?
This trial is for individuals with obstructive sleep apnea (OSA) who have a certain level of nighttime breathing difficulty or low oxygen levels. Women can join if they use birth control, and participants must have normal thyroid function unless treated. People with high liver enzymes, diabetes, pregnancy plans within six months, or allergies to statins cannot participate.Check my eligibility
What is being tested?
The study investigates how atorvastatin affects fat tissue in OSA patients already using CPAP therapy. Participants will either receive atorvastatin or a placebo without knowing which one they're taking to compare the effects objectively.See study design
What are the potential side effects?
Atorvastatin may cause muscle pain, fatigue, digestive issues like nausea or constipation, and rarely more serious problems such as liver damage or increased blood sugar levels.

SCAT-OSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in prevalence of dual positive p16IND4A and gamma H2AX cells in adipose tissue
Secondary outcome measures
Changes in 24- h mean arterial pressure
Changes in body composition
Changes in insulin sensitivity
+2 more

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069
3%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

SCAT-OSA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtorvastatinExperimental Treatment1 Intervention
Subjects randomized to this arm will be started on a lower dose of atorvastatin 40 mg daily for the first 4 weeks. If they are tolerating this dose without significant problems, atorvastatin will be increased to 80 mg daily.
Group II: Placebo Oral CapsulePlacebo Group1 Intervention
Subjects randomized to this arm will receive placebo capsules matching study drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,734 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,446 Total Patients Enrolled
Prachi Singh, Ph.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Atorvastatin Clinical Trial Eligibility Overview. Trial Name: NCT03308578 — Phase 1 & 2
Obstructive Sleep Apnea Research Study Groups: Atorvastatin, Placebo Oral Capsule
Obstructive Sleep Apnea Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT03308578 — Phase 1 & 2
Atorvastatin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03308578 — Phase 1 & 2
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03308578 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical situations is Atorvastatin commonly prescribed?

"Atorvastatin is primarily used to address dyslipidemias, but can also be beneficial for postoperative thromboembolism, angina pectoris and transient ischemic attack."

Answered by AI

Is the enrollment window for this research still available?

"Clinicialtrials.gov reports that this study, originally posted on August 1st 2018 and last edited March 4th 2022, is no longer seeking patients for enrollment. That said, 362 other trials are still actively recruiting participants."

Answered by AI

How many participants are included in the ongoing clinical research?

"This trial is no longer recruiting, having been last updated on March 4th 2022. If you are in search of similar studies related to sleep apnea or Atorvastatin, there are currently 291 and 71 active trials respectively."

Answered by AI

Does this clinical research represent an unprecedented breakthrough?

"Currently, 71 Atorvastatin clinical trials are ongoing in 162 cities and 28 countries. Merck Sharp & Dohme LLC ran the first study of its kind back in 2005 which managed to complete Phase 4 drug approval stages with 80 participants. This initial trial has been followed by 640 more studies over 15 years since then."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have sleep apnea and elevated cholesterol. Considering taking a statin but haven’t acted on that yet.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Statins and CPAP in Adipose Tissue of OSA
Virend Somers, MD, PhD 2018. "Statins and CPAP in Adipose Tissue of OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03308578.
~7 spots leftby Apr 2025
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