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Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

NCT06655649 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-10

No results posted yet for this study

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.

\[Aim 2: Examine the preliminary efficacy of ingesting exogenous ketones before sleep on OSA\]

Conditions

Interventions

DIETARY_SUPPLEMENT

Ketone-IQ (1,3 Butanediol)

Ketone-IQ (1,3 Butanediol) 20 or 40 g will be ingested (open-label) before bedtime.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Jun, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655649 on ClinicalTrials.gov