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Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations
Sponsor: Johns Hopkins University
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. Our 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 pharmacokinetics, tolerability, and sleep impacts of ingesting exogenous ketones before sleep in patients with sleep apnea, while under treatment for OSA. \[Aim 2: Examine the preliminary efficacy of ingesting exogenous ketones before sleep on OSA\]
Official title: Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations: Phase I Study (KETO-SLEEP 1)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-01-29
Completion Date
2030-06-01
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Ketone-IQ (1,3 Butanediol)
Ketone-IQ (1,3 Butanediol) 20 or 40 g will be ingested (open-label) before bedtime.
Locations (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States