Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-31 @ 9:26 AM
Study NCT ID:
NCT06866132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to an Investigational Device in Patients With Restless Legs Syndrome
Sponsor:
Noctrix Health, Inc.
Organization:
Study Overview
Official Title:
Form, Fit and Function Feasibility Study
Status:
ACTIVE_NOT_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:
None
Brief Summary:
This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.
The IRB has established that the investigational device is non-significant risk.
The IRB has established that the investigational device is non-significant risk.
Detailed Description:
In this 12-week study, participants complete a 2-week baseline (no intervention) followed by 8-weeks of investigational medical device intervention (weeks 3-10) followed by 2-weeks with no intervention (weeks 11-12).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: