A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Whole Food Ketogenic Diet
BehavioralEducation 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).
Whole Food Diet
BehavioralEducation 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Whole Food Ketogenic Diet (WFKD)Experimental treatment 1 intervention
Group B: Whole Food Diet (WFD)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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
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.
Time frame
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
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.
Time frame
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.Secondary outcomes
1
Sleep Outcomes - average sleep onset latency
The key sleep efficacy outcome is the average sleep onset latency in minutes measured across 5 trials of the maintenance of wakefulness test (MWT) at 12 weeks compared with baseline.
Time frame
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.2
Sleep Outcomes - markers of sleep micro-architecture
Markers of sleep micro-architecture during PSG including sleep onset latency, REM onset latency, sleep duration, sleep efficiency measured at 12 weeks compared with baseline.
Time frame
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.3
Sleep Outcomes - Narcolepsy Severity Scale (for NT1 and NT2)
Change in Narcolepsy Severity Scale measured at 12 weeks compared with baseline and 3 weeks. The Narcolepsy Severity Scale is a 15-item self-reported outcome measure validated for use in NT1 patients. It evaluates the severity, frequency, and impact of the 5 main narcolepsy symptoms (EDS, cataplexy, hallucinations, sleep paralysis, and disrupted night-time sleep). Total score ranges from 0 to 57, with higher scores indicating more severe symptoms. Except for cataplexy, these narcolepsy symptoms are also relevant for some NT2 patients, and thus, we will use the Narcolepsy Severity Scale in both NT1 and NT2 patients.
Time frame
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.4
Sleep Outcomes - Idiopathic Hypersomnia Severity Scale (for IH)
Change in Idiopathic Hypersomnia Severity Scale measured at 12 weeks compared with baseline and 3 weeks. The Idiopathic Hypersomnia Severity Scale is a self-reported measure validated in patients with IH. It is a 14-item questionnaire that measures aspects of night-time and daytime sleep symptoms and the sleep inertia related to each, as well as impaired daytime functioning due to hypersomnolence. Symptom frequency, intensity, and consequences are rated using a 3- or 4-point scale. Total score ranges from 0 to 50, with higher scores indicating more severe and frequent symptoms.
Time frame
From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sydney
Lead sponsor
Woolcock Institute of Medical Research
Collaborator
Source ClinicalTrials.gov