Clinical trial NCT06866132: Response to an Investigational Device in Patients With Restless Legs Syndrome
Official title: Form, Fit and Function Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Restless Legs Syndrome
Lead sponsor: Noctrix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Change in IRLS Rating Scale Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Mean change in the number of nights with RLS per week
timeFrame: 10 weeks
measure: Mean Change in MOS-II
timeFrame: 10 weeks
measure: Mean Change in MOS-I
timeFrame: 10 weeks
measure: Mean PGI-I score
timeFrame: 10 weeks
measure: Percent of Patients Reporting Much Improved or Very Much Improved
timeFrame: 10 weeks
measure: Mean Change in Periodic Limb Movement Index (PLMI)
timeFrame: 10 weeks
measure: Mean Change in Sleep Efficiency Percentage
timeFrame: 10 weeks
measure: Mean Change in Minutes Awake after Sleep Onset (WASO)
timeFrame: 10 weeks
measure: Mean Change in Total Sleep Time (TST)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Noctrix Health Headquarters
state: California
Study officials:
affiliation: Noctrix Health, Inc.
name: Jonathan D Charlesworth, PhD
role: STUDY_DIRECTOR
References: