Can a bedtime ketone drink help sleep apnea sufferers?
NCT ID NCT06655649
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether drinking a ketone supplement (Ketone-IQ) before bed can improve sleep quality and reduce sleep apnea severity in 30 adults who already use a CPAP machine. Participants will try two different doses and compare effects to a placebo. The goal is to find a simple, well-tolerated option for people who struggle with standard treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged 18-65 years old with a BMI of 18 - 35 kg/m2 2. History of moderate-severe OSA as defined by AHI \>15 events/hr (American Academy of Sleep Medicine criteria), 3. Adherent to CPAP (objectively determined via device download over last 30 days) using CPAP at least 70% of days for \>=4 hours. 4. CPAP pressure ≤10 cm water (H2O) (based on prescribed CPAP pressure, or median pressure on an auto-titrating CPAP device). Exclusion Criteria: 1. No concomitant sleep disorder (such as insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia) 2. No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled chronic obstructive pulmonary disease (COPD), pneumonia, interstitial lung disease. 3. No use of supplemental oxygen. 4. Currently on a low carbohydrate (\<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones 5. Pregnancy or breastfeeding 6. Alcohol consumption of \> 10 standard drinks per week 7. Use of nightly medications that affect breathing (e.g. opiates, acetazolamide) 8. Use of Sodium-glucose cotransporter-2 (SGLT2) inhibitors. For example, Canagliflozin (Invokana), Dapagliflozin (Farxiga), Empagliflozin (Jardiance), Ertugliflozin (Steglatro)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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