Ketone-IQ for Sleep Apnea

(KETO-SLEEP 2 Trial)

This trial explores whether Ketone-IQ, a type of exogenous ketone (a substance produced by the body during a keto diet), can improve sleep quality and reduce the severity of obstructive sleep apnea (OSA), a condition that disrupts breathing during sleep. Participants will use Ketone-IQ and a placebo (a substance with no active ingredient) on different nights to observe any differences. The trial targets individuals with moderate to severe OSA who regularly use a CPAP machine (a device that keeps airways open during sleep). As a Phase 1, Phase 2 trial, the research aims to understand how Ketone-IQ works in people and to measure its effectiveness in an initial, smaller group.

The trial requires you to stop using nightly medications that affect breathing and Sodium-glucose cotransporter-2 (SGLT2) inhibitors. If you are taking these, you will need to stop before participating.

Earlier studies have shown that Ketone-IQ, which contains 1,3 butanediol, may benefit brain function and overall health. This suggests it has been generally well-received in past uses. Although specific safety information for sleep apnea is limited, current research is examining short-term responses to Ketone-IQ. As a purchasable product, many have used it without major issues. However, since testing for sleep apnea is still in early stages, participation in studies is crucial to confirm its safety and effectiveness for this condition.¹²³⁴⁵

Unlike the standard treatments for sleep apnea, such as CPAP machines and oral appliances, Ketone-IQ offers a novel approach by utilizing ketone bodies to potentially improve sleep quality. Researchers are keen to explore this treatment because ketone bodies might enhance brain energy metabolism during sleep, which is a different mechanism than simply mechanically supporting airways. This innovative angle could lead to better patient compliance and offer benefits beyond what's currently available.

This trial will evaluate the effects of Ketone-IQ on sleep apnea. Research has shown that a low-carb, high-fat ketogenic diet can reduce the severity of obstructive sleep apnea (OSA). Since following this diet can be challenging, supplements like Ketone-IQ might offer a useful alternative. Studies have found that these supplements can improve sleep quality, especially after intense exercise. The idea is that taking Ketone-IQ before bed could raise ketone levels overnight, potentially alleviating OSA symptoms. Although human research on Ketone-IQ for OSA is limited, early studies suggest a positive effect. Participants in this trial will experience both Ketone-IQ and placebo treatments in a crossover design to assess its impact on OSA.¹²³⁶⁷