Ketone-IQ for Sleep Apnea

(KETO-SLEEP 2 Trial)

Overseen by Jonathan Jun, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Obstructive Sleep Apnea (OSA) is a common medical disorder that is associated with reduced quality of life and higher risk of cardiovascular disease. Treatments for OSA and limited and not well tolerated. The investigator's lab has shown that a low carbohydrate, high fat ketogenic diet (KD) can reduce OSA severity. Since it can be challenging to adhere to a ketogenic diet, the investigators propose that ingesting exogenous ketones can be an alternative method to improve OSA. Specifically the investigators will examine the effect of taking a commercially available product (Ketone-IQ) at bedtime on overnight ketones and sleep quality. The investigators will also examine the effect of Ketone-IQ on sleep apnea severity, compared to placebo. This project will examine the the preliminary efficacy of ingesting exogenous ketones before sleep on sleep apnea.

Research Team

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with moderate to severe sleep apnea.

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

Exclusion Criteria

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

I do not use supplemental oxygen.

Currently on a low carbohydrate (<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones

Treatment Details

Interventions

• Ketone-IQ (Other)

Trial Overview 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.

Participant Groups

Group I: Placebo first Experimental Treatment 2 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 first Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

HVMN Inc

Industry Sponsor

Trials

3

Recruited

80+

KETONE-IQ

Collaborator

Trials

2

Recruited

60+