Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07006233
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07006233
Study Brief:
Protocol Section:
NCT07006233