Restless Legs SyndromeRESTNCT03852771
REST Study (CompRESsion Therapy for RLS)
A study testing Cirvo(TM) therapy in people with Restless Legs Syndrome, run by Radial Medical, Inc. at 1 site in United States.
Trial summary
This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Cirvo(TM) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over the age of 18.
- Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
- International RLS Study Group (IRLSS) Score ≥15.
- RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Who cannot join
- Known or suspected deep vein thrombosis.
- Pregnancy
- Prior use with home intermittent pneumatic compression (IPC) device
- Currently using any other device to treat RLS
- Active skin infections in the affected leg
- Vein ligation or skin graft of the leg within past 12 months
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- Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
- Physical impairments that would prevent the use of the CirvoTM device.
- Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
- If previously on medication to treat RLS, patient must have been weened under medical supervision and off medication for at least 14 days at time of enrollment
- History of pulmonary vascular disease (PVD)
- History of pulmonary edema
- History of decompensated congestive heart failure (CHF)
- Open surgery or major trauma to the legs within the last six months
- History of lower limb malignancy, primary or secondary
- Acute symptomatic lower extremity thrombophlebitis
- Any chronic back pain or lower extremity pain
- Other sleep problems that are felt to be currently affecting the quality of sleep
- Calf geometry on which Cirvo™ device does not appropriately fit
- Known sensitivity to any of the materials used in the Cirvo™ device
- Currently participating or plans to participate in in any other investigational clinical evaluation during the 56 day study period that may, in the opinion of the investigator, affect RLS.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Center for Sleep Disorders
Alameda, California, 94501
About this study
Official title: CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome
This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.
- Conditions
- Restless Legs Syndrome
- Being tested
- Cirvo(TM) therapy
- 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.
Cirvo(TM) therapyDevice
The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression to the lower leg.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All participants will receive the intervention Receives: Device: Cirvo(TM) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS).
Assessment of change in IRLSS scores from Baseline study visit to 56 days.
Measured: 56 days
Secondary outcomes (3)
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the Clinical Global Impression (CGI-I) rating scale.
Change in disease severity as assessed by CGI-I scale
Measured: 56 days
Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.
Change in sleep quality as assessed by MOS sleep scale from Baseline to 56 days
Measured: 56 days
Change in disease severity between the Baseline study visit and after the last usage of the each parameter set trialed in Period 1 (nominally days 7, 14, 21, and 28), as assessed by the IRLSS.
Assessment of IRLSS score after each week of programmed therapy for first 4 weeks of therapy.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start12 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: Company closure
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radial Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852771
- Sponsor's protocol ID
- CL-00383
- Acronym
- REST
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT03852771
- Acronym / sponsor ID
- REST / CL-00383
- Conditions
- Restless Legs Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company closure
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Radial Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 Feb 2019 (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 in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Cirvo(TM) therapyAll participants will receive the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female over the age of 18.
- Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
- International RLS Study Group (IRLSS) Score ≥15.
- RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Key exclusion criteria (21 listed)
- Known or suspected deep vein thrombosis.
- Pregnancy
- Prior use with home intermittent pneumatic compression (IPC) device
- Currently using any other device to treat RLS
- Active skin infections in the affected leg
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 |
|---|---|---|
| Cirvo(TM) therapyThe Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression to the lower leg. | Device | Treatment |
Primary outcome
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS).
Time frame: 56 days
Assessment of change in IRLSS scores from Baseline study visit to 56 days.
3 secondary outcomes
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the Clinical Global Impression (CGI-I) rating scale.
Time frame: 56 days
Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.
Time frame: 56 days
Change in disease severity between the Baseline study visit and after the last usage of the each parameter set trialed in Period 1 (nominally days 7, 14, 21, and 28), as assessed by the IRLSS.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Company closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cirvo(TM) therapy in people with Restless Legs Syndrome, run by Radial Medical, 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 4 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Feb 2020. 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?
The study was stopped early (reason given: Company closure). Results are not available in the source record.
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?
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS). (time frame: 56 days). 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 10 Feb 2020.