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SUSPENDED
NCT06655649
PHASE1

Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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