Restless Legs SyndromeNCT06866132
Response to an Investigational Device in Patients With Restless Legs Syndrome
A study testing Investigational Noninvasive Neuromodulation Device in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Investigational Noninvasive Neuromodulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
- - Subject has received a medical diagnosis of primary restless legs syndrome.
- - 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.
- - 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.
- - 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,
- - Subject reports that RLS symptoms are most significant in lower legs and/or feet.
Who cannot join
- - The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
- - The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
- - The subject has been diagnosed with epilepsy or other seizure disorder.
- - The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
- - 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).
- - Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
Show all 14Show fewer
- - The subject is unable or unwilling to comply with study requirements.
- - The subject has a medical condition not listed above that may put them at risk.
- - Subject has prior experience with any neurostimulation devices developed by the study sponsor
- - 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).
- - On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of >60min.
- - 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.
- - 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.
- - During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range
Trial locations and contacts
1 site in 1 country.
United States1 site
Noctrix Health Headquarters
Pleasanton, California, 94566
About this study
Official title: Form, Fit and Function Feasibility Study
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.
Read the 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
- Being tested
- Investigational Noninvasive Neuromodulation Device
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Noninvasive Neuromodulation DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device Protocol | Experimental | Participants will use the investigational noninvasive neuromodulation device as instructed over a period of 8 weeks (weeks 3 through 10). Receives: Device: Investigational Noninvasive Neuromodulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in IRLS Rating Scale Score
International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed from study entry to Week 10.
Measured: 10 weeks
Secondary outcomes (9)
Mean change in the number of nights with RLS per week
This outcome measures the change in subject-reported number of nights with RLS, which ranges from 0 to 7 for each time point assessed. The mean change is assessed from study entry to Week 10. A greater decrease represents a better outcome.
Measured: 10 weeks
Mean Change in MOS-II
The Medical Outcomes Study Sleep Problems Index II (MOS-II) score is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. The mean change is assessed from study entry to Week 10.
Measured: 10 weeks
Mean Change in MOS-I
The Medical Outcomes Study Sleep Problems Index II (MOS-II) score is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. The mean change is assessed from study entry to Week 10.
Measured: 10 weeks
Mean PGI-I score
The Patient Global Impressions of Improvement (PGI-I) score assesses the patient's perception of their condition's improvement from study entry, with scores ranging from: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). The mean is assessed at Week 10 relative to study entry.
Measured: 10 weeks
Percent of Patients Reporting Much Improved or Very Much Improved
The Responder Rate is the percentage of subjects with a Patient Global Impressions of Improvement (PGI-I) rating of Much Improved or Very Much Improved relative to study entry. The scores for the Patient Global Impressions of Improvement (PGI-I) are: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7).
This endpoint assesses the responder rate at Week 10.
Measured: 10 weeks
Mean Change in Periodic Limb Movement Index (PLMI)
Mean change in the total number of periodic limb movements (PLMs) per hour of sleep from Weeks 1-2 to Weeks 9-10. A greater decrease in PLMs per hour corresponds to a better outcome.
Measured: 10 weeks
Mean Change in Sleep Efficiency Percentage
Sleep efficiency (SE) is the percentage of the time a person spends asleep relative to the total time dedicated to sleep. A better outcome corresponds to a percentage closer to 100%. This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10.
Measured: 10 weeks
Mean Change in Minutes Awake after Sleep Onset (WASO)
Minutes Awake after Sleep Onset (WASO) refer to the total number of minutes awake after first going to sleep and before waking up for the next day in the morning. Lower WASO corresponds to a better outcome.
This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10.
Measured: 10 weeks
Mean Change in Total Sleep Time (TST)
Total sleep times (TST) refers to the total minutes of sleep starting at bedtime until waking up in the next morning. Higher TST corresponds to a better outcome.
This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start11 Mar 2025
- Primary completion4 Aug 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noctrix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan D Charlesworth, PhD, Study director, Noctrix Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866132
- Sponsor's protocol ID
- CT-07
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to the investigational nature of the device, IPD will not be shared for this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Form, Fit and Function Feasibility Study
- ClinicalTrials.gov ID
- NCT06866132
- Acronym / sponsor ID
- CT-07
- Conditions
- Restless Legs Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Noctrix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Device Protocol | Experimental | Device: Investigational Noninvasive Neuromodulation DeviceParticipants will use the investigational noninvasive neuromodulation device as instructed over a period of 8 weeks (weeks 3 through 10). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
- - Subject has received a medical diagnosis of primary restless legs syndrome.
- - 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.
- - 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.
- - 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,
Key exclusion criteria (14 listed)
- - The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
- - The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
- - The subject has been diagnosed with epilepsy or other seizure disorder.
- - The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Noninvasive Neuromodulation DeviceThe 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. | Device | Investigational Device Protocol |
Primary outcome
Mean Change in IRLS Rating Scale Score
Time frame: 10 weeks
International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed from study entry to Week 10.
9 secondary outcomes
Mean change in the number of nights with RLS per week
Time frame: 10 weeks
Mean Change in MOS-II
Time frame: 10 weeks
Mean Change in MOS-I
Time frame: 10 weeks
Mean PGI-I score
Time frame: 10 weeks
Percent of Patients Reporting Much Improved or Very Much Improved
Time frame: 10 weeks
Mean Change in Periodic Limb Movement Index (PLMI)
Time frame: 10 weeks
Mean Change in Sleep Efficiency Percentage
Time frame: 10 weeks
Mean Change in Minutes Awake after Sleep Onset (WASO)
Time frame: 10 weeks
Mean Change in Total Sleep Time (TST)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No. Due to the investigational nature of the device, IPD will not be shared for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D Charlesworth, PhD study director
Noctrix Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Noninvasive Neuromodulation Device in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in IRLS Rating Scale Score (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.