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New treatment option for Idiopathic Hypersomnia
Official title A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
ClinicalTrials.gov ID: NCT07006233
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Evidence (from multiple sleep latency test, 24-hour polysomnography, or actigraphy) of diagnosis of narcolepsy type 1, narcolepsy type 2 or...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Macquarie Park, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Macquarie Park, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.