Clinical trial NCT03852771: REST Study (CompRESsion Therapy for RLS)
Official title: CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Restless Legs Syndrome
Lead sponsor: Radial Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female over the age of 18.
2. Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
3. International RLS Study Group (IRLSS) Score ≥15.
4. RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.

Exclusion Criteria:

1. Known or suspected deep vein thrombosis.
2. Pregnancy
3. Prior use with home intermittent pneumatic compression (IPC) device
4. Currently using any other device to treat RLS
5. Active skin infections in the affected leg
6. Vein ligation or skin graft of the leg within past 12 months
7. Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
8. Physical impairments that would prevent the use of the CirvoTM device.
9. Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
10. 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
11. History of pulmonary vascular disease (PVD)
12. History of pulmonary edema
13. History of decompensated congestive heart failure (CHF)
14. Open surgery or major trauma to the legs within the last six months
15. History of lower limb malignancy, primary or secondary
16. Acute symptomatic lower extremity thrombophlebitis
17. Any chronic back pain or lower extremity pain
18. Other sleep problems that are felt to be currently affecting the quality of sleep
19. Calf geometry on which Cirvo™ device does not appropriately fit
20. Known sensitivity to any of the materials used in the Cirvo™ device
21. 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.

Primary outcomes:
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).
timeFrame: 56 days
Secondary outcomes:
measure: 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.
timeFrame: 56 days
measure: Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.
timeFrame: 56 days
measure: 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.
timeFrame: 28 days
Other outcomes:
measure: Therapy related adverse events
timeFrame: 56days
Locations:
city: Alameda
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
References: