ACTIVE_NOT_RECRUITING

Response to an Investigational Device in Patients With Restless Legs Syndrome

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Form, Fit and Function Feasibility Study

Quick Facts

Study Start:2025-03-11

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06866132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. - Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English 2. - Subject has received a medical diagnosis of primary restless legs syndrome. 3. - Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines. 4. - Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry. 5. - Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry, 6. - Subject reports that RLS symptoms are most significant in lower legs and/or feet.	1. - The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators). 2. - The subject has a metal implant at the site of the study device electrode application (not including knee replacements). 3. - The subject has been diagnosed with epilepsy or other seizure disorder. 4. - The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study. 5. - The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages). 6. - Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores 7. - The subject is unable or unwilling to comply with study requirements. 8. - The subject has a medical condition not listed above that may put them at risk. 9. - Subject has prior experience with any neurostimulation devices developed by the study sponsor 10. - Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion). 11. - On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min. 12. - Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS. 13. - Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work. 14. - During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range

Inclusion Criteria

Exclusion Criteria

1. - Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English
2. - Subject has received a medical diagnosis of primary restless legs syndrome.
3. - Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.
4. - Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
5. - Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry,
6. - Subject reports that RLS symptoms are most significant in lower legs and/or feet.

1. - The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
2. - The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
3. - The subject has been diagnosed with epilepsy or other seizure disorder.
4. - The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
5. - The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
6. - Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
7. - The subject is unable or unwilling to comply with study requirements.
8. - The subject has a medical condition not listed above that may put them at risk.
9. - Subject has prior experience with any neurostimulation devices developed by the study sponsor
10. - Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
11. - On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.
12. - Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
13. - Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
14. - During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range

Contacts and Locations

Principal Investigator

Jonathan D Charlesworth, PhD

STUDY_DIRECTOR

Noctrix Health, Inc.

Study Locations (Sites)

Noctrix Health Headquarters

Pleasanton, California, 94566

United States

Collaborators and Investigators

Sponsor: Noctrix Health, Inc.

Jonathan D Charlesworth, PhD, STUDY_DIRECTOR, Noctrix Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-03-11

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Restless Legs Syndrome