Actively Recruiting
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Led by University of Sydney · Updated on 2025-08-27
30
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
W
Woolcock Institute of Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia based on sleep tests meeting ICSD-3 criteria
- For narcolepsy type 1, positive screening for HLA DQB10602 genotype
- Body mass index greater than 18.5 kg/m2
- Age 18 years or older
- Willingness to change diet including animal protein and fat
- Willingness to monitor ketones using finger-prick and urinary dipstick tests
- Habitual diet includes moderate or high carbohydrate intake (above 130g per day)
- Willing to provide informed consent and comply with study requirements
- Access to a computer, tablet, smartphone, or laptop with stable internet
- Proficient in English and able to understand study materials, with support person if needed
You will not qualify if you...
- Body mass index less than 18.5 kg/m2 or history of eating disorder with high severity score
- Significant weight loss (>5%) in past 3 months
- Previous bariatric surgery or current use of weight loss medication
- Unstable psychiatric disorders except anxiety or depression
- Cognitive or physical impairments limiting study participation
- Non-English speaking or unable to read study information
- No access to stable internet or device for telehealth and questionnaires
- Pregnant, lactating, or of childbearing potential unwilling to avoid pregnancy during study
- Habitual low carbohydrate or ketogenic diet (less than 130g carbohydrate per day)
- Habitual diet excludes animal products (e.g., vegan diet)
- Abnormal laboratory tests indicating other causes of hypersomnolence
- Medication changes within 4 weeks prior to study
- History of inherited metabolic disorders, hypoglycemia, or insulinoma
- Insulin-dependent diabetes prescribed insulin
- Uncontrolled medical conditions or significant comorbidities posing health risks
- Current cancer diagnosis except skin or benign cancers
- Participation in other clinical trials or investigational drug use within last 12 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
Research Team
E
Elizabeth A Machan, PhD
CONTACT
F
Francis Cheong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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