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Ketone-IQ first for Obstructive 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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 nights ketone-iq, 2 nights placebo

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Obstructive Sleep Apnea
Sleep

Eligibility Criteria

Inclusion Criteria

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

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

Awards & Highlights

No Placebo-Only Group

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

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 / 4Eligibility criteria met