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Bedtime ketone drink tested as new sleep apnea aid

NCT ID NCT06687655

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests whether drinking a ketone supplement (Ketone-IQ) before sleep can improve sleep quality and reduce breathing pauses in people with moderate-to-severe obstructive sleep apnea. Thirty adults who already use CPAP will try the ketone drink for two nights and a placebo for two nights, then compare results. The goal is to find an easier alternative to a strict ketogenic diet for managing sleep apnea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ketone-IQ (1,3 Butanediol)
What this could lead to
If it works, this could offer a simple, diet-free way to reduce sleep apnea severity and improve sleep quality.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply widely. The ketone drink may cause stomach discomfort and might not improve sleep apnea at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Started

Jan 2025

Finished

Sep 2026

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Ketosis obstructive sleep apnea syndrome sleep apnea syndrome sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea Sleep

Contacts and locations

Locations

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.