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Response to an Investigational Device in Patients With Restless Legs Syndrome

NCT06866132 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

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.

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D Charlesworth, PhD · Noctrix Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2025-08-04
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866132 on ClinicalTrials.gov