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Impact of Exogenous Ketones on Sleep Apnea

Study acronym: KETO-SLEEP 2
StatusWithdrawn
PhasePhase 1/2
Started2025-01-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Withdrawn before enrolling
Trial withdrawn: Change in protocol due to requirement for IND
Primary completion confirmed: September 2026 (last estimated September 2028)
2025-10-08
Study Status, Study Description v5
Study description-66 characters
[...] in a commercially available formulation called "Ketone IQ". 1,3BD is generally recognized as safe (GRAS approved) by the FDA. 1,3BD is converted by liver metabolism into the ketone body [...]
2025-09-18
Study Status v4
Primary completion date2026-09-01→2028-09-06
Completion date2026-09-01→2028-09-06
Start date2025-09-01→2026-09-06
2025-04-25
Study Status v3
Primary completion date2026-06-01→2026-09-01
Completion date2026-06-01→2026-09-01
Start date2025-07-01→2025-09-01
2025-02-20
Study Status v2
Start date2025-01-31→2025-07-01
2024-12-09
Study Status v1
Start date2024-12-01→2025-01-31
2024-11-12
Original filing
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. The investigator's 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 the preliminary efficacy of ingesting exogenous ketones before sleep on sleep apnea.
Trial Details
NCT Number NCT06687655
Lead Sponsor Johns Hopkins University
Collaborators: HVMN Inc, KETONE-IQ
Conditions Obstructive Sleep Apnea, Sleep
Start Date 2025-01-29
Primary Completion 2026-09-15 (estimated)
Study Completion 2026-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-21