Status:
NOT_YET_RECRUITING
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
HVMN Inc
KETONE-IQ
Conditions:
Healthy Participants
Sleep
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 re...
Detailed Description
There is growing interest leveraging ketone metabolism for human health and performance. Exogenous ketones (EK) are substances that directly increase circulating ketones in the body without requiring ...
Eligibility Criteria
Inclusion
- Adults aged 18-50 years old with a BMI of 18 - 30 kg/m\^2
Exclusion
- No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion.
- No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease.
- No known history of chronic renal disease or diabetes (type 1 or type 2).
- No use of supplemental oxygen.
- Cannot be on a low carbohydrate (\<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
- Cannot be pregnancy or breastfeeding
- Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor (10), daily opioid use.
- K-BREATHE: no history of claustrophobia or panic disorder
- Frequent alcohol intake (more than 1 drink per day on average, or \> 10 drinks per week).
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07224074
Start Date
January 1 2026
End Date
January 1 2028
Last Update
November 3 2025
Active Locations (1)
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1
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224