Actively Recruiting
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
Led by Johns Hopkins University · Updated on 2026-01-14
20
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
H
HVMN Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ketones are molecules generated by the body during the metabolism of fat. Exogenous ketones (EK) are substances that can raise the level of ketones in the circulation without changing diet. In this research study, the investigators are testing the tolerability, sleep effects, and dose effects of a commercially available EK product called Ketone-IQ. The investigators will administer Ketone-IQ open-label to healthy volunteers (n=20, 10 men, 10 women) before sleep in the participant's home setting and collect information about subjective sleep and GI symptoms, as well as objective data about beta-hydroxybutyrate (BHB) levels and sleep architecture using a headband-EEG device (Sleep Profiler). Participants will measure capillary BHB levels before ingestion and at 1, 3, and 5 hours post-ingestion, as well as upon awakening. Questionnaires will be used to gather feedback on the palatability of EK, GI side effects, and sleep quality. Higher scores indicate better sleep quality. Two doses (20 g and 40 g) of Ketone-IQ will be tested each for two nights, with one night used to measure BHB levels and a separate night to allow for uninterrupted sleep.
CONDITIONS
Official Title
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Body mass index (BMI) between 18 and 30 kg/m2
You will not qualify if you...
- Known sleep disorders such as sleep apnea, insomnia, restless leg syndrome, narcolepsy, or idiopathic hypersomnia
- STOP-BANG score of 5 or higher without a known diagnosis of sleep apnea
- Current daytime respiratory impairment including uncontrolled asthma, COPD, pneumonia, or interstitial lung disease
- History of chronic kidney disease or diabetes (type 1 or 2)
- Use of supplemental oxygen
- Following a low carbohydrate (<130 g/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
- Pregnancy or breastfeeding
- Use of medications including acetazolamide, SGLT2 inhibitors, or daily opioids
- History of claustrophobia or panic disorder (for K-BREATHE study component)
- Frequent alcohol consumption (more than 1 drink per day or over 10 drinks per week)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
M
Mariah V Potocki, Bachelors of Science
CONTACT
A
Athena Mavronis, Associates of Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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