An interventional study of Investigational Extended Duration (XD-) TOMAC Therapy and Tonic Motor Activation (TOMAC) Therapy in Restless Legs Syndrome (RLS), sponsored by Noctrix Health, Inc.. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Noctrix Health, Inc. (part of ResMed) · Not applicable, Interventional, and Treatment
Among 107 studies in Restless Legs Syndrome with a site in United States — 9 open to participants now, 13 under way, none of them phase 3. Restless Legs Syndrome · United States.
Among the 107 studies in Restless Legs Syndrome with a site in United States, this one is the 66th largest by planned enrollment of the 95 interventional ones that give a count, is one of 2 that started in 2026, is one of 30 with no phase, reaches primary completion later than 7 of the 12 other live ones, and was the 106th registered.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
Browse Restless Legs Syndrome studies →9 of the 107 studies in Restless Legs Syndrome with a site in United States are open now. Recruiting first, the newest first:
Rhode Island Hospital · Sites in United States
University of Alabama at Birmingham · Sites in United States
HBC Immunology Inc · Sites in United States
Stanford University · Sites in United States
Endeavor Health · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Restless Legs Syndrome studies recruiting now, 10 (40%) set no upper age limit and 12 (48%) stop at 75 or younger; 0 take children under 18; 10 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
107 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 23 · Phase 3 21 · Phase 4 18
First in 1995; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 20 is below the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Median enrollment 46 across the 95 interventional studies, 72 across the 12 observational. Of the 83 that completed or were terminated, 35 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
50 of 107 have an industry lead sponsor. The 10 most frequent:
Noctrix Health, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Noctrix Health, Inc. has 9 studies filed under Restless Legs Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Restless Legs Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02670161Endeavor HealthQuality Improvement and Practice Based Research in Neurology Using the EMR | 2026-12 |
| NCT07675109Noctrix Health, Inc.Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS) | 2026-12 |
| NCT07061470Hugo W. Moser Research Institute at Kennedy Krieger, Inc.A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep | 2027-07-31 |
Among the 107 studies in Restless Legs Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
In this 12-week study, participants complete a 1-week baseline (no intervention) followed by 1-week Tonic Motor Activation (TOMAC) therapy (30-minutes of stimulation). Next, participants complete 4-weeks of Extended Duration (XD-) TOMAC. Then, participants will complete investigational TOMAC medical device interventions for 6-weeks in a pseudo-randomized order.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Device: Investigational Extended Duration (XD-) TOMAC Therapy · Device: Tonic Motor Activation (TOMAC) Therapy
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Device: Investigational Extended Duration (XD-) TOMAC Therapy · Device: Tonic Motor Activation (TOMAC) Therapy
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Device: Investigational Extended Duration (XD-) TOMAC Therapy · Device: Tonic Motor Activation (TOMAC) Therapy
The investigational noninvasive neuromodulation device will be setup by the participant at bedtime and used to provide Extended Duration Tonic Motor Activation (XD-TOMAC) every night. The IRB has established that the investigational device is non-significant risk.
Also known as: Noninvasive Neuromodulation, XD-TOMAC
The noninvasive neuromodulation device will be setup by the participant to be used for TOMAC 30-minute stimulation therapy sessions as needed during the 2nd week of the study and as appropriate for the remainder of the study. The IRB has established that the device is non-significant risk.
Also known as: Noninvasive Neuromodulation, TOMAC
Number of RLS-related awakenings per night
This outcome measures the number of awakenings per night that were related to RLS symptoms. A lower number represents a better outcome. Assessed via daily sleep diary and compared for each intervention to the Baseline period
Time frame: 12 weeks
Mean change in International RLS Study Group Rating Scale (IRLS) total 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 over the final week of each intervention and compared to assessment at Study Entry.
Time frame: 12 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%. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Time frame: 12 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. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Time frame: 12 weeks
Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R)
Minutes Awake after Sleep Onset (WASO-R) refer to the total number of minutes awake with RLS symptoms after first going to sleep and before waking up for the next day in the morning. Lower WASO-R corresponds to a better outcome. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Time frame: 12 weeks
Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score
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 over the final 2-weeks of each intervention and compared to assessment at Study Entry.
Time frame: 12 weeks
Patient Global Impressions - Improvement (PGI-I) responder rate
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). Assessed over the final week of each intervention.
Time frame: 12 weeks
Plan to share: No — Due to the investigational nature of the device, IPD will not be shared for this study.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 53 interventional studies with no phase under Restless Legs Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 40. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.