← Back to Search

Dietary Supplement

Exogenous Ketones for Obstructive Sleep Apnea (KETO-SLEEP 1 Trial)

Phase 1

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

Adults aged 18-65 years old with a BMI of 18 - 35 kg/m2

History of moderate-severe OSA as defined by AHI >15 events/hr (American Academy of Sleep Medicine criteria)

Must not have

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

No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled chronic obstructive pulmonary disease (COPD), pneumonia, interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up night 2, night 5

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if taking a product called Ketone-IQ before bedtime can improve obstructive sleep apnea (OSA) by increasing ketones in the body. The researchers believe that ingesting

Who is the study for?

This trial is for people with Obstructive Sleep Apnea (OSA), a condition that disrupts sleep and can lead to health problems. Participants should be currently receiving treatment for OSA but are looking for additional ways to improve their sleep quality.

What is being tested?

The study tests if taking Ketone-IQ, an exogenous ketone supplement, at bedtime can improve overnight ketones and sleep quality in OSA patients. It compares the effects of this supplement to a placebo on how severe the sleep apnea is.

What are the potential side effects?

Possible side effects from ingesting Ketone-IQ may include gastrointestinal discomfort, bad taste, potential metabolic changes, or allergic reactions. The full range of side effects will be studied as part of the trial.

Eligibility Criteria

Inclusion Criteria

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

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.

Select...

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

Exclusion Criteria

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

Select...

I do not have any sleep disorders.

Select...

I do not have any uncontrolled breathing problems during the day.

Select...

I do not use supplemental oxygen.

Select...

I take medications at night that can affect my breathing.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ night 2, night 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~night 2, night 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and night 2, night 5 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Beta hydroxybutyrate (BHB) maximal concentration (Cmax)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketone InterventionExperimental Treatment1 Intervention

Participants with sleep apnea using CPAP will undergo open-label procedures. They will ingest (1) nothing, (2) Ketone IQ 20 g or (3) Ketone IQ 40 g before bedtime and undergo objective and subjective sleep assessments.

0 / 8Eligibility criteria met