Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 7:52 AM
Study NCT ID:
NCT07006233
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Sponsor:
University of Sydney
Organization:
Study Overview
Official Title:
A Novel Dietary Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPANION
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.
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.
Detailed Description:
The primary objectives of COMPANION are:
• To determine the feasibility and tolerability of a 12-week whole-food ketogenic diet (WFKD) compared to an isocaloric standard whole-food diet (WFD) in participants with hypersomnolence (HS) as defined by the RE-AIM Framework.
The secondary objectives are:
* To determine whether a WFKD achieves greater improvements in disease relevant sleep outcomes including excessive daytime sleepiness, reduced duration of sleep onset latency and psychomotor vigilance compared to an isocaloric WFD in participants with HS.
* To determine whether a WFKD achieves greater improvements in objective metabolic health outcomes and subjective quality of life outcomes compared to an isocaloric WFD in participants with HS.
* To determine whether patients prefer a combination of dietary intervention and medication or unique dietary intervention compared to traditional medication only treatments in their lived experience.
* To better understand the context for implementation of both dietary interventions, determining the barriers and facilitators to widespread implementation of the dietary intervention.
A prospective, mixed methods, randomised, single-centre, controlled trial (Hybrid Type 1) with two parallel groups comparing the feasibility of a WFKD to a WFD stratified by patient diagnosis of NT1, NT2 or IH. This project will determine whether patients with persistent HS can feasibly sustain dietary changes in addition to usual care, and if so, whether improvements in symptoms of daytime sleepiness, metabolic health and quality of life outcomes can be enhanced with a WFKD. At the core of this project is the delivery of a 12-week dietary intervention, in which all patients will be initially allocated to a WFD for three weeks. At the commencement of week four, participants will be randomised to either maintain consumption of this WFD or combine with carbohydrate restriction to form a WFKD for the remaining nine weeks.
The inclusion of a three-week run-in period for all patients provides confidence to the design that patients entering randomisation can engage with dietary change, and thus will provide our first indicator of feasibility. The WFD group from this point on will serve as a comparator in this randomised clinical trial.
• To determine the feasibility and tolerability of a 12-week whole-food ketogenic diet (WFKD) compared to an isocaloric standard whole-food diet (WFD) in participants with hypersomnolence (HS) as defined by the RE-AIM Framework.
The secondary objectives are:
* To determine whether a WFKD achieves greater improvements in disease relevant sleep outcomes including excessive daytime sleepiness, reduced duration of sleep onset latency and psychomotor vigilance compared to an isocaloric WFD in participants with HS.
* To determine whether a WFKD achieves greater improvements in objective metabolic health outcomes and subjective quality of life outcomes compared to an isocaloric WFD in participants with HS.
* To determine whether patients prefer a combination of dietary intervention and medication or unique dietary intervention compared to traditional medication only treatments in their lived experience.
* To better understand the context for implementation of both dietary interventions, determining the barriers and facilitators to widespread implementation of the dietary intervention.
A prospective, mixed methods, randomised, single-centre, controlled trial (Hybrid Type 1) with two parallel groups comparing the feasibility of a WFKD to a WFD stratified by patient diagnosis of NT1, NT2 or IH. This project will determine whether patients with persistent HS can feasibly sustain dietary changes in addition to usual care, and if so, whether improvements in symptoms of daytime sleepiness, metabolic health and quality of life outcomes can be enhanced with a WFKD. At the core of this project is the delivery of a 12-week dietary intervention, in which all patients will be initially allocated to a WFD for three weeks. At the commencement of week four, participants will be randomised to either maintain consumption of this WFD or combine with carbohydrate restriction to form a WFKD for the remaining nine weeks.
The inclusion of a three-week run-in period for all patients provides confidence to the design that patients entering randomisation can engage with dietary change, and thus will provide our first indicator of feasibility. The WFD group from this point on will serve as a comparator in this randomised clinical trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 316-SR-23 | OTHER_GRANT | American Academy of Sleep Medicine Foundation | View |