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SGLT2 Inhibitor

Ertugliflozin for Sleep Apnea (ADIPOSA Trial)

Phase 4
Waitlist Available
Led By Ian J Neeland, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods: Polysomnography: AHI ≥15/hour sleep or Home sleep apnea testing: Respiratory event index (REI) ≥15/hour sleep
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights

ADIPOSA Trial Summary

This trial tests if a drug can reduce sleep apnea severity in overweight/obese adults w/ moderate-severe OSA vs. a placebo. Participants will get routine care and undergo tests to check drug effectiveness.

Who is the study for?
The ADIPOSA study is for overweight or obese adults with moderate to severe obstructive sleep apnea (OSA). Participants must be able to consent, follow the study plan for 6 months, and have a confirmed OSA diagnosis. Excluded are those planning certain weight loss treatments, with hypersensitivity to the drug tested, pregnant women, users of sleep-inducing meds, and individuals with specific medical conditions or inability to undergo MRI.Check my eligibility
What is being tested?
This trial tests if Ertugliflozin can reduce the severity of sleep apnea in comparison to a placebo. It examines whether improvements in clinical measures of OSA result from changes in anatomic and physiologic traits. Participants will receive either the drug or placebo alongside routine care for six months while undergoing various clinical measurements.See study design
What are the potential side effects?
Potential side effects may include urinary tract infections, genital mycotic infections due to SGLT2 inhibitors like Ertugliflozin. The exact side effects will be monitored throughout the trial as participants' reactions can vary.

ADIPOSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with obstructive sleep apnea with an AHI or REI of 15 or more.

ADIPOSA Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
Secondary outcome measures
Change in 24 hour ambulatory average diastolic blood pressure
Change in 24 hour ambulatory average systolic blood pressure
Change in 24 hour ambulatory blood pressure variability
+24 more

ADIPOSA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BexagliflozinExperimental Treatment1 Intervention
Bexagliflozin once daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily for 6 months

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,249 Total Patients Enrolled
2 Trials studying Sleep Apnea
117 Patients Enrolled for Sleep Apnea
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,923 Total Patients Enrolled
Ian J Neeland, M.D.Principal InvestigatorCase Western Reserve University School of Medicine

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05612594 — Phase 4
Sleep Apnea Research Study Groups: Bexagliflozin, Placebo
Sleep Apnea Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT05612594 — Phase 4
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612594 — Phase 4

Frequently Asked Questions

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

Are there still openings for participants in this trial?

"Based on the information located at clinicaltrials.gov, this medical research is no longer recruiting patients as it was last updated November 3rd 2022. Nevertheless, there are presently 257 other trials actively looking for participants right now."

Answered by AI

Is Ertugliflozin a risk-free option for people?

"With Ertugliflozin being an approved treatment, it has been awarded a score of 3 for safety."

Answered by AI
~109 spots leftby Sep 2027