Actively Recruiting
A Novel Dietary 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
N/A
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
Researchers are evaluating how changes in diet affect sleepiness, quality of life, and metabolic health in adults living with narcolepsy and idiopathic hypersomnia. This trial focuses on two dietary approaches: a whole-food ketogenic diet and a standard whole-food diet, aiming to provide additional lifestyle options beyond medication for managing symptoms. This area of research is new for hypersomnolence conditions but builds on evidence of safety and benefits in other chronic and neurological conditions. The study is a 12-week randomized controlled trial with two groups. All participants start with a three-week period consuming a standard whole-food diet. After this run-in, they are randomly assigned to either continue the standard whole-food diet or switch to a whole-food ketogenic diet that limits carbohydrates to 30-50 grams per day to achieve nutritional ketosis. Both diets focus on unprocessed or minimally processed foods, with the ketogenic diet targeting specific ketone levels monitored through blood and urine tests. Participants will be involved in dietary changes and monitored for feasibility, tolerability, and compliance throughout the 12 weeks. Assessments include measures of sleep quality and sleepiness, metabolic health markers, mood, quality of life surveys, and dietary adherence using ketone levels and sleep diaries. Data collection involves interviews and questionnaires to understand patient experiences and preferences. The study aims to assess whether these diet changes can be sustained and improve health outcomes alongside usual care.
CONDITIONS
Brief Title
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia confirmed by sleep tests
- 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 urine tests
- Habitual diet with moderate or high carbohydrate intake (above 130g/day)
- Willingness to provide informed consent and comply with study requirements
- Access to a computer, tablet, or smartphone with stable internet
- Ability to understand English and availability of support during consultations if needed
You will not qualify if you...
- Body mass index less than 18.5 kg/m2 or history of eating disorder with high EDE-Q score
- Significant weight loss over 5% in the last 3 months
- Previous bariatric surgery or current weight loss medication
- Unstable psychiatric disorders (excluding anxiety or depression)
- Cognitive or physical impairments limiting study participation
- Inability to read English participant information
- No access to stable internet or device for telehealth
- Pregnant, lactating, or unwilling to avoid pregnancy during study
- Current low carbohydrate or ketogenic diet (less than 130g/day)
- Vegan diet excluding animal products
- Abnormal lab results suggesting other causes of hypersomnolence
- Medication changes in the last 4 weeks
- Inherited metabolic disorders or history of hypoglycemia or insulinoma
- Insulin-dependent diabetes using insulin
- Uncontrolled medical conditions or significant comorbidities
- Current cancer diagnosis excluding skin or benign cancers
- Participation in other drug or intervention trials in last 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 3 weeks
Participants follow a whole-food diet aimed at improving diet quality before randomization.
Weekly visits for 3 weeks
Duration - 9 weeks
Participants are randomized to continue the whole-food diet or switch to a whole-food ketogenic diet with carbohydrate restriction to manage symptoms of hypersomnolence.
Weekly visits for 9 weeks
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
F
Francis Cheong
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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