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Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

Description

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. Our 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 pharmacokinetics, tolerability, and sleep impacts of ingesting exogenous ketones before sleep in patients with sleep apnea, while under treatment for OSA. \[Aim 2: Examine the preliminary efficacy of ingesting exogenous ketones before sleep on OSA\]

Conditions

Obstructive Sleep ApneaSleep
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Related Conditions:

Obstructive Sleep ApneaSleep

Study Overview

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Study Details

Study overview

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. Our 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 pharmacokinetics, tolerability, and sleep impacts of ingesting exogenous ketones before sleep in patients with sleep apnea, while under treatment for OSA. \[Aim 2: Examine the preliminary efficacy of ingesting exogenous ketones before sleep on OSA\]

Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations: Phase I Study (KETO-SLEEP 1)

Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Jonathan Jun, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-06-01