A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

NCT07006233 | Recruiting

• 2 other identifiers: COMPANION316-SR-23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Hypersomnia; Narcolepsy Type 1 (NT 1); Narcolepsy Type 2 (NT2)

Keywords

keto diet; ketogenic; keto; whole food diet; narcolepsy; idiopathic hypersomnia; low carb; hypersomnolence; diet; dietary intervention; diet intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility - using quantitative measures of feasibility

  A suite of quantitative measures of feasibility (i.e. recruitment rate related to the number of patients considered for eligibility, screened, enrolled and the time frames associated with reaching the target sample size) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Feasibility - using quantitative measures of tolerability

  A suite of quantitative measures of tolerability (measured by dietary protocol adherence, rate of attrition during both the run in and intervention phase and quantity and nature of adverse events) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Feasibility - using quantitative measures of compliance

  A suite of quantitative measures of compliance (measured by capillary and urinary ketones and food diaries) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

Secondary Outcomes (29)

• Sleep Outcomes - average sleep onset latency

  From baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Sleep Outcomes - markers of sleep micro-architecture

  From baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Sleep Outcomes - Narcolepsy Severity Scale (for NT1 and NT2)

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Sleep Outcomes - Idiopathic Hypersomnia Severity Scale (for IH)

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

• Sleep Outcomes - weekly cataplexy rate

  From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

Study Arms (2)

Whole Food Ketogenic Diet (WFKD)

EXPERIMENTAL

Following a 3 week whole food diet run-in, participants will reduce their carbohydrate intake to 30-50g per day to achieve nutritional ketosis.

Behavioral: Whole Food Ketogenic Diet

Whole Food Diet (WFD)

ACTIVE COMPARATOR

Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate).

Behavioral: Whole Food Diet

Interventions

Whole Food Ketogenic Diet BEHAVIORAL

Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This group will focus on the consumption of low-energy, nutrient dense whole foods with a targeted carbohydrate intake of 30-50g per day to achieve nutritional ketosis. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood/urinary ketone levels of between 0.5 and 3.0 mmol/L (tested for objective feedback using a mix of urinary ketone sticks and finger prick blood measures).

Also known as: WFKD, Keto Diet, ketogenic diet

Whole Food Ketogenic Diet (WFKD)

Whole Food Diet BEHAVIORAL

Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate, 20-35% from fat and 15-25% from protein) based on the Australian dietary guidelines focusing on the consumption of low-energy, nutrient dense whole foods. The higher carbohydrate diet reflects current contemporary 'standard care' dietary recommendations as outlined by the National Health and Medical Research Council's Australian Dietary Guidelines, and therefore represents the most appropriate control diet to compare to the effects of the proposed intervention.

Also known as: WFD, Minimally Processed Diet

Whole Food Diet (WFD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• University of Sydney: lead
• Woolcock Institute of Medical Research: collaborator

Study Sites (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia; Narcolepsy; Disorders of Excessive Somnolence

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elizabeth A Machan, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Sheila Sivam, PhD; MD; FracP; BSc (Med)

  Royal Prince Alfred Hospital and University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Machan, PhD

CONTACT

+61408 290 687; elizabeth.machan@sydney.edu.au

Francis Cheong

CONTACT

+61 2 9805 3293; francis.cheong@woolcock.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding: Single-blinded study (assessor for baseline and post-intervention data blinded). Interviewers for semi-structured interviews will also be blinded (which includes principal investigator).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective mixed methods clinician led randomised controlled hybrid type 1 study

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 5, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)