A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
A Novel Dietary Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
University of Sydney
30 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria10
- 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
- years or over
- Be willing to be involved in dietary change that may include animal protein and fat.
- Be willing to monitor ketones via finger-prick and urinary dipstick.
- Habitual diet is a standard diet consuming a moderate or high carbohydrate level (defined for the study as above 130g carbohydrate/day).
- Willingness to provide informed consent and willingness to participate and comply with the study requirements.
- Access to a computer, laptop, tablet, or smartphone and stable internet access.
- Proficient comprehension of English language (able to independently read information sheet) and availability of a support person during consultations if English comprehension is challenged.
Exclusion Criteria18
- 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).
- Cognitive impairment that limits ability to understand the study requirements or provide informed consent.
- Physical impairment that limits ability to meet the study requirements.
- Non-English speaking and inability to read the Participant Information Sheet.
- No access to stable internet and device on which to participate in telehealth consultations and complete study questionnaires.
- Person lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study period.
- Habitual diet is currently low carbohydrate/ketogenic (defined for the study as <130g carbohydrate/day based on screening 24 food hour recall).
- Habitual diet excludes animal products (e.g. Vegan diet).
- Laboratory parameters that may indicate alternate catalyst for hypersomnolence in the opinion of the study physician, including abnormal: full blood count, thyroid function, Epstein-Barr Virus, erythrocyte sedimentation rate, cortisol, antinuclear antibodies, extractable nuclear antigen test, positive rheumatoid factor, Antistreptolysin O positive, Iron studies or multiple biochemistry panel.
- Participants who have changed their medication prescription or dose within the preceding 4 weeks.
- Participants with inherited metabolic disorders, prior history of hypoglycaemia or insulinoma
- Participants with insulin dependent Type 1 or Type 2 diabetics prescribed insulin which may interfere with the participant's ability to meet the study requirements.
- Participants with uncontrolled medical conditions or patients with significant medical co-morbidities who in the opinion of the study physician, would be at risk of adverse health consequences due to the study intervention (e.g. poorly controlled type 2 diabetic patients who are not prescribed insulin)
- Current cancer diagnosis (excluding skin cancers or benign cancers)
- Current active enrolment in a pharmaceutical or intervention based clinical trial or participant who may have received an investigational new drug within the last 12 weeks.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This group will focus on the consumption of low-energy, nutrient dense whole foods with a targeted carbohydrate intake of 30-50g per day to achieve nutritional ketosis. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood/urinary ketone levels of between 0.5 and 3.0 mmol/L (tested for objective feedback using a mix of urinary ketone sticks and finger prick blood measures).
Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate, 20-35% from fat and 15-25% from protein) based on the Australian dietary guidelines focusing on the consumption of low-energy, nutrient dense whole foods. The higher carbohydrate diet reflects current contemporary 'standard care' dietary recommendations as outlined by the National Health and Medical Research Council's Australian Dietary Guidelines, and therefore represents the most appropriate control diet to compare to the effects of the proposed intervention.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07006233