Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07006233 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

Study acronym: COMPANION
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 30, 2026 to Jun 2026
    • Start date changed from estimate of Jun 1, 2025 to Jun 23, 2025
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07006233
Lead Sponsor University of Sydney
Collaborators: Woolcock Institute of Medical Research
Conditions
(from sponsor)
Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1), Narcolepsy Type 2 (NT2)
Related terms Disorders of Excessive Somnolence, Idiopathic Hypersomnia, Narcolepsy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov