NCT06866132

Response to an Investigational Device in Patients With Restless Legs Syndrome

Form, Fit and Function Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DEVICE	Investigational Noninvasive Neuromodulation Device	The investigational noninvasive neuromodulation device will be setup by the patient at bedtime and will be used every night. The IRB has established that the investigational device is non-significant risk.

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-08-04
• Completion: 2025-09-30
• First posted: 2025-03-10
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study