← Back to Search

Other

Ketone-IQ for Sleep Apnea (KETO-SLEEP 2 Trial)

Phase 1 & 2

Waitlist Available

Led By Jonathan Jun, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adherent to CPAP (objectively determined via device download over last 30 days) using CPAP at least 70% of days for >=4 hours

CPAP pressure ≤10 cm water (H2O) (based on prescribed CPAP pressure, or median pressure on an auto-titrating CPAP device)

Must not have

No use of supplemental oxygen

No concomitant sleep disorder (such as insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 nights ketone-iq, 2 nights placebo

Summary

This trial aims to test if taking a product called Ketone-IQ before bedtime can improve sleep quality and reduce the severity of obstructive sleep apnea. The researchers believe that ingesting exogenous ket

Who is the study for?

This trial is for individuals with Obstructive Sleep Apnea (OSA), a condition that disrupts sleep and increases heart disease risk. Participants should be interested in trying an alternative to the challenging ketogenic diet by taking Ketone-IQ at bedtime to potentially improve their sleep quality and reduce OSA severity.

What is being tested?

The study tests if drinking Ketone-IQ, an exogenous ketone product, before sleeping can help manage OSA better than a placebo. It aims to see whether this approach can increase overnight ketones and enhance sleep quality without adhering strictly to a ketogenic diet.

What are the potential side effects?

While specific side effects are not listed, exogenous ketones may cause gastrointestinal discomfort such as stomach ache, nausea, diarrhea or constipation in some people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I use my CPAP machine regularly, at least 4 hours on 70% of days.

Select...

My CPAP pressure is set at or below 10 cm water.

Select...

I am between 18 and 65 years old with a BMI between 18 and 35.

Select...

I have been diagnosed with moderate to severe sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not use supplemental oxygen.

Select...

I do not have any sleep disorders like insomnia or narcolepsy.

Select...

I do not have uncontrolled breathing problems during the day.

Select...

I take medications at night that can affect my breathing.

Select...

I am currently taking medication for diabetes that includes drugs like Invokana, Farxiga, Jardiance, or Steglatro.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 nights ketone-iq, 2 nights placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 nights ketone-iq, 2 nights placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 nights ketone-iq, 2 nights placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apnea Hypopnea Index (AHI)

Secondary study objectives

Gastrointestinal Symptoms Questionnaire

Nadir Oxygen Level

Oxygen Desaturation Index

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo firstExperimental Treatment2 Interventions

This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This arm will ingest Placebo first, then Ketone-IQ.

Group II: Ketone-IQ firstExperimental Treatment2 Interventions

This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This arm will ingest Ketone-IQ first, then placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility criteria met