A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

Ki vehet részt

• 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
• 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

Ki nem vehet részt

• Previous bariatric surgery or current prescription of weight loss medication
• 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
• 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
• Body mass index <18.5 kg/m2, history of an eating disorder with an EDE-Q score greater than 3
• 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
• 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)
• 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 sustained significant weight loss in the last 3 months (>5% change in total body weight)
• 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)
• 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