A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia (NCT07006233) | Clinical Trial Compass
RecruitingNot Applicable
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Australia30 participantsStarted 2025-06-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility - using quantitative measures of feasibility
Timeframe: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
2
Feasibility - using quantitative measures of tolerability
Timeframe: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
3
Feasibility - using quantitative measures of compliance
Timeframe: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.