Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations

A vizsgálat adatai

Ki végzi

Johns Hopkins University

Azonosító

NCT06655649

A regiszteradat frissítve

2026. június 23.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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]

Bevonási feltételek: 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).

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

ClinicalTrials.gov NCT06655649