A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health.
If effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.
Eligibility criteria
Qualifiers
Evidence (from multiple sleep latency test, 24-hour polysomnography, or actigraphy) of diagnosis of narcolepsy type 1, narcolepsy type 2 or idiopathic hypersomnia that meets ICSD-3 criteria.
For the NT1 subtype, patients must have been screened positive for the HLA DQB10602 genotype.
Body mass index >18.5 kg/m2
18 years or over
Disqualifiers
Body mass index <18.5 kg/m2, history of an eating disorder with an EDE-Q score greater than 3.
Participants who have sustained significant weight loss in the last 3 months (>5% change in total body weight).
Previous bariatric surgery or current prescription of weight loss medication.
Diagnosis of unstable psychiatric disorders (excluding anxiety or depression).
Trial design
Treatments tested in this trial
- Whole Food Ketogenic Diet
- Whole Food Diet
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Sydney
Lead sponsor
Woolcock Institute of Medical Research
Collaborator
Source ClinicalTrials.gov