Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837091
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-04-19
Brief Title:
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Low sodium oxybate has been approved by the US Food and Drug Administration FDA for the treatment of idiopathic hypersomnia In this study the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time In addition this study will use novel tools to determine when an individual is awake or asleep
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None