Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

NCT06655649 | Suspended Phase 1

• 1 other identifier: IRB00439273
• 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. 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 Apnea; Sleep

Keywords

sleep apnea; ketones; CPAP

Outcome Measures

Primary Outcomes (1)

• Beta hydroxybutyrate (BHB) maximal concentration (Cmax)

  Participants will measure their capillary BHB levels at home at 4 time points after ingestion (1, 3, 5 hours, and final awakening). The investigators will derive the maximal BHB concentration (mmol) of these timepoints. Measured on two occasions: Night 2 (Ketone IQ 20 g) and Night 5 (Ketone IQ 40 g).

  Night 2, Night 5

Study Arms (1)

Ketone Intervention

EXPERIMENTAL

Participants with sleep apnea using CPAP will undergo open-label procedures. They will ingest (1) nothing, (2) Ketone IQ 20 g or (3) Ketone IQ 40 g before bedtime and undergo objective and subjective sleep assessments.

Dietary Supplement: Ketone-IQ (1,3 Butanediol)

Interventions

Ketone-IQ (1,3 Butanediol) DIETARY_SUPPLEMENT

Ketone-IQ (1,3 Butanediol) 20 or 40 g will be ingested (open-label) before bedtime.

Ketone Intervention

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

Interventions

1,3-butylene glycol

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with a history of moderate-severe sleep apnea, who are using CPAP, will be included. KETO-SLEEP 1 (n=20) will examine the pharmacokinetics, GI tolerability, and sleep impacts of ingesting open-label Ketone-IQ (1,3-butanediol) before sleep at 2 doses (20 or 40 g). All sleep studies are performed at home while using CPAP. at home. Some nights will involve ingesting Ketone-IQ before bedtime and wearing a sleep monitoring device (Sleep Profiler). Other nights involve waking up to check capillary ketone levels. Questionnaires will be given to ask about sleep quality and GI tolerability.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• 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)