Clinical Trial

A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

Study acronym: COMPANION
Recruiting
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Record status
This record was last updated August 27, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-27.
Status change: Not Yet Recruiting → Recruiting 2025-08-20
Trial Details
NCT Number NCT07006233
Lead Sponsor University of Sydney
Collaborators: Woolcock Institute of Medical Research
Conditions Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1), Narcolepsy Type 2 (NT2)
Enrollment 30 participants
Start Date 2025-06-23
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-27