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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07006233




Registration number
NCT07006233
Ethics application status
Date submitted
5/05/2025
Date registered
5/06/2025
Date last updated
5/06/2025

Titles & IDs
Public title
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Scientific title
A Novel Dietary Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Secondary ID [1] 0 0
316-SR-23
Secondary ID [2] 0 0
COMPANION
Universal Trial Number (UTN)
Trial acronym
COMPANION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Hypersomnia 0 0
Narcolepsy Type 1 (NT 1) 0 0
Narcolepsy Type 2 (NT2) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Whole Food Ketogenic Diet
BEHAVIORAL - Whole Food Diet

Experimental: Whole Food Ketogenic Diet (WFKD) - Following a 3 week whole food diet run-in, participants will reduce their carbohydrate intake to 30-50g per day to achieve nutritional ketosis.

Active comparator: Whole Food Diet (WFD) - 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 Ketogenic Diet
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).

BEHAVIORAL: Whole Food Diet
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility - using quantitative measures of feasibility
Timepoint [1] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Primary outcome [2] 0 0
Feasibility - using quantitative measures of tolerability
Timepoint [2] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Primary outcome [3] 0 0
Feasibility - using quantitative measures of compliance
Timepoint [3] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [1] 0 0
Sleep Outcomes - average sleep onset latency
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Sleep Outcomes - markers of sleep micro-architecture
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Sleep Outcomes - Narcolepsy Severity Scale (for NT1 and NT2)
Timepoint [3] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [4] 0 0
Sleep Outcomes - Idiopathic Hypersomnia Severity Scale (for IH)
Timepoint [4] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [5] 0 0
Sleep Outcomes - weekly cataplexy rate
Timepoint [5] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [6] 0 0
Sleep Outcomes - Karolinska Sleepiness Scale
Timepoint [6] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [7] 0 0
Sleep Outcomes - Epworth Sleepiness Scale
Timepoint [7] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [8] 0 0
Sleep Outcomes - Psychomotor Vigilance Task (PVT)
Timepoint [8] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [9] 0 0
Exploratory Sleep Outcomes - quantitative analysis of the EEG from PSG data
Timepoint [9] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [10] 0 0
Cardio-metabolic and Quality of Life Outcomes - high sensitivity C-reactive protein (hs-CRP)
Timepoint [10] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [11] 0 0
Cardio-metabolic and Quality of Life Outcomes - 36-Item Short Form Survey summary scores
Timepoint [11] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [12] 0 0
Cardio-metabolic and Quality of Life Outcomes - laboratory blood analyses
Timepoint [12] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [13] 0 0
Cardio-metabolic & Quality of Life Outcomes - anthropometry and vitals data
Timepoint [13] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [14] 0 0
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using 36-Item Short Form Survey
Timepoint [14] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [15] 0 0
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using Hospital Anxiety and Depression Scale
Timepoint [15] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [16] 0 0
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using EQ-5D-5L
Timepoint [16] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [17] 0 0
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using Clinical Global Impression
Timepoint [17] 0 0
At the end of 12 weeks for the last enrolled participant.
Secondary outcome [18] 0 0
Demographics & diagnostic history
Timepoint [18] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [19] 0 0
Adherence and lived experience during intervention - diet satisfaction
Timepoint [19] 0 0
From the end of 3 weeks to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [20] 0 0
Adherence and lived experience during intervention - macronutrient/micronutrient change
Timepoint [20] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [21] 0 0
Adherence and lived experience during intervention - dietary adherence measured by blood ketosis level
Timepoint [21] 0 0
From the baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [22] 0 0
Adherence and lived experience during intervention - dietary adherence measured by urine ketosis level
Timepoint [22] 0 0
From the baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [23] 0 0
Adherence and lived experience during intervention - habitual actigraphy sleep-wake data
Timepoint [23] 0 0
From week -1 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [24] 0 0
Adherence and lived experience during intervention - habitual sleep diary sleep-wake data
Timepoint [24] 0 0
From week -1 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [25] 0 0
Adherence and lived experience during intervention - Patient Reported Experience Measures - Longitudinal PREM
Timepoint [25] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [26] 0 0
Adherence and lived experience during intervention - Patient Reported Experience Measures - Patient Assessment of Chronic Illness Care
Timepoint [26] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [27] 0 0
Adherence and lived experience during intervention - Patient Reported Experience Measures - Outpatient PREM
Timepoint [27] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [28] 0 0
Qualitative Data - semi-structured interviews
Timepoint [28] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Secondary outcome [29] 0 0
Qualitative Data - overall project evaluation
Timepoint [29] 0 0
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Macquarie Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Woolcock Institute of Medical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth A Machan, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elizabeth A Machan, PhD
Address 0 0
Country 0 0
Phone 0 0
+61408 290 687
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07006233