P024 A novel dietary protocol to manage symptoms of hypersomnolence

Abstract Introduction There is a paucity of evidence related to behavioural interventions for people living with hypersomnolence. No effective non-pharmacological treatments have been rigorously explored. The proposed study proposes a novel dietary intervention for hypersomnolence. Methods A randomised, controlled, single-centre, type 1 hybrid feasibility trial with two parallel groups will be conducted; stratified by condition subgroup (narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia). This project will determine whether patients with hypersomnolence can feasibly sustain dietary changes in addition to usual care, and whether symptoms of daytime sleepiness, metabolic health and quality of life outcomes are enhanced with a whole food ketogenic diet (WFKD). The project plans to recruit 30 participants (10 per subgroup) and consists of a 12-week dietary intervention and all patients will be initially allocated to a whole food diet (WFD) eliminating ultra-processed foods for three weeks. From week four, participants will be randomised to sustain the WFD or restrict carbohydrates (WFKD) for nine weeks. Dietary compliance will be monitored through ketones. Outcomes related to feasibility, implementation, metabolic health, and quality of life will be measured at 0, 3 and 12-weeks. Maintenance of wakefulness testing and polysomnography will be measured at 0 and 12-weeks. Qualitative data will be collected through semi-structured interviews related to patient experience and project evaluation. Conclusion If feasible and effective, an adjunct WFKD may improve disease relevant sleep outcomes, metabolic health, and quality of life in patients with hypersomnolence. The study will provide insight into dietary implementation, including barriers and facilitators for upscaling.