Impact of Exogenous Ketones on Sleep Apnea

NCT06687655 | Not Yet Recruiting Phase 1

• 1 other identifier: IRB00439273-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Sleep

Keywords

sleep apnea; ketones; CPAP

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  Sleep studies will be performed using NOX T3 devices at home. The device will be worn for 2 consecutive nights during each intervention (Ketone IQ, Placebo); 4 nights total (2 nights Ketone-IQ, 2 nights Placebo). Apnea hypopnea index (AHI); mean number of apnoeas and hypopnoeas per hour of sleep will be calculated from NOX T3 data.

  2 nights Ketone-IQ, 2 nights Placebo

Secondary Outcomes (7)

• Gastrointestinal Symptoms Questionnaire

  2 mornings after Ketone-IQ, 2 mornings after Placebo

• Sleep-Related Impairment (SRI) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI 8a)

  2 mornings after Ketone-IQ, 2 mornings after Placebo

• Sleep Disturbance (SD) as assessed by the PROMIS SD

  2 mornings after Ketone-IQ, 2 mornings after Placebo

• Stanford Sleepiness Scale (SSS)

  2 mornings after Ketone-IQ, 2 mornings after Placebo

• Oxygen Saturation Level

  2 nights on Ketone IQ, 2 nights on placebo

Study Arms (2)

Ketone-IQ first

EXPERIMENTAL

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.

Dietary Supplement: Ketone-IQ; Dietary Supplement: Placebo

Placebo first

EXPERIMENTAL

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.

Dietary Supplement: Ketone-IQ; Dietary Supplement: Placebo

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.

Ketone-IQ first; Placebo first

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.

Ketone-IQ first; Placebo first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years old with a BMI of 18 - 35 kg/m2
• History of moderate-severe OSA as defined by AHI \>15 events/hr (American Academy of Sleep Medicine criteria),
• Adherent to CPAP (objectively determined via device download over last 30 days) using CPAP at least 70% of days for \>=4 hours.
• CPAP pressure ≤10 cm water (H2O) (based on prescribed CPAP pressure, or median pressure on an auto-titrating CPAP device).

You may not qualify if:

• No concomitant sleep disorder (such as insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia)
• No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled chronic obstructive pulmonary disease (COPD), pneumonia, interstitial lung disease.
• No use of supplemental oxygen.
• Currently on a low carbohydrate (\<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
• Pregnancy or breastfeeding
• Alcohol consumption of \> 10 standard drinks per week
• Use of nightly medications that affect breathing (e.g. opiates, acetazolamide)
• Use of Sodium-glucose cotransporter-2 (SGLT2) inhibitors. For example, Canagliflozin (Invokana), Dapagliflozin (Farxiga), Empagliflozin (Jardiance), Ertugliflozin (Steglatro)

Sponsors & Collaborators

• Johns Hopkins University: lead
• HVMN Inc: collaborator
• KETONE-IQ: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Ketosis

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah Potocki

CONTACT

410-550-2233; mchaney7@jhmi.edu

Athena Mavronis

CONTACT

410-550-4588; amavron1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will examine the preliminary efficacy of ingesting exogenous ketones before sleep on OSA. Patients with known OSA will be asked to temporarily discontinue CPAP, a technique used in our laboratory to temporarily elicit OSA. Prior to sleep the participants will ingest Ketone-IQ (20 g to 40 g - dose to be determined by KETO-SLEEP 1 trial), or placebo. Sleep will be assessed using a home sleep test (NOX T3) and questionnaires. Glucose will be monitored using a continuous glucose monitor (CGM).

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start (Estimated): September 6, 2026
• Primary Completion (Estimated): September 6, 2028
• Study Completion (Estimated): September 6, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified scientific data included in published manuscripts will be made available at the time of publication and additional data will be made available to researchers upon request. Data will be made available for up to 3 years following study completion.
• Access Criteria: To request access to the data, researchers will be able to contact Dr. Jonathan Jun via email. Any data attached as a supplement to publications will be available for download from the publisher's website. The intention is to allow qualified external investigators broad access to the study data for specified research purposes.

Locations

US (1)