Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

Paused · Phase 1

Conditions studied: Obstructive Sleep Apnea, Sleep

In brief

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

Key facts

Study ID: NCT06655649
Run by: Johns Hopkins University
People needed: 30
Starts: 2025-01-29
Expected to finish: 2030-06-01
Last updated by the study team: 2026-06-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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),
Adherent to CPAP (objectively determined via device download over last 30 days) using CPAP at least 70% of days for >=4 hours.
CPAP pressure ≤10 cm water (H2O) (based on prescribed CPAP pressure, or median pressure on an auto-titrating CPAP device).

You may not qualify if…

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.
No use of supplemental oxygen.
Currently on a low carbohydrate (<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
Pregnancy or breastfeeding
Alcohol consumption of > 10 standard drinks per week
Use of nightly medications that affect breathing (e.g. opiates, acetazolamide)
Use of Sodium-glucose cotransporter-2 (SGLT2) inhibitors. For example, Canagliflozin (Invokana), Dapagliflozin (Farxiga), Empagliflozin (Jardiance), Ertugliflozin (Steglatro)

Where it is running

Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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