Impact of Exogenous Ketones on Sleep Apnea

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06687655
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketone-IQ — DIETARY_SUPPLEMENT
    This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This is the Ketone-IQ (1,3 Butanediol) intervention.
  • Placebo — DIETARY_SUPPLEMENT
    This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This is the Placebo intervention.

Study Details

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.

Key Dates

Start date
Sep 6, 2026
Status verified
Oct 2025
Primary completion
Sep 6, 2028
Completion
Sep 6, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ketone-IQ first
    This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This arm will ingest Ketone-IQ first, then placebo.
  • Experimental: Placebo first
    This is a crossover study where participants will ingest either Ketone-IQ for 2 nights, or placebo for 2 nights before sleep. This arm will ingest Placebo first, then Ketone-IQ.

Primary Outcome Measure

Apnea Hypopnea Index (AHI) [ Time Frame: 2 nights Ketone-IQ, 2 nights Placebo ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Mariah Potocki
[email protected]
410-550-2233

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Bayview Medical Center· Baltimore, MD

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