Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept

NCT00867893 | Completed

• 1 other identifier: Sit-AUG
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Some medications used to treat the restless legs syndrome (RLS) when taken for some time make the condition worse. This study seeks to find a method for early detection of this problem so that it can either be prevented or corrected.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (7)

• Periodic Leg Movement/Hour on SIT PSG

  Occurs one month after Baseline SIT.

  1 Month

• Periodic Leg Movement/Hour on SIT PSG

  Occurs 2 months after Baseline SIT.

  2 Month

• Periodic Leg Movement/Hour on SIT PSG

  Occurs 4 months after Baseline SIT.

  4 Month

• Periodic Leg Movement/Hour on SIT PSG

  Occurs 6 months after Baseline SIT.

  Month 6

• Periodic Leg Movement/Hour on SIT PSG

  Occurs 9 months after Baseline SIT.

  Month 9

• Periodic Leg Movement/Hour on SIT PSG

  Occurs 12 months after Baseline SIT.

  12 Month

• Periodic Leg Movement/Hour on SIT PSG

  First SIT used as a baseline, 1 or 2 days depending on participant's past experience with the test.

  0 months/Baseline

Study Arms (2)

DA group

RLS patients started treatment on dopamine agonists within the past year

NonDA

RLS patients started treatment on medication other than dopamine agonists within the past year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RLS patients treated with medication

You may qualify if:

• Primary RLS (exclude all secondary RLS including those related to neuropathies and medications)
• Adult and adolescents 18 years of age or older
• One of the following 2 criteria must be met:
• RLS treatment with either ropinirole or pramipexole or with a non-DA treatment (opioid or GABA active hypnotic), with the first dose each day taken at or before 4:30 PM. (Note this allows patients to be entered who had the usual tapered withdrawal from another medication with a concurrent gradual start of the DA agonist or opioid over a period of up to 12 months. In all such cases the initial evaluations must occur at least 6 weeks after discontinuing any prior drug treatment.) OR
• Off all RLS medication treatments for at least 6 weeks AND planning on starting DA agonist or a non-DA treatment (opioid or GABA active hypnotic) as the only RLS medication treatment.

You may not qualify if:

• Pregnant or lactating.
• Inadequate birth control if female and able to become pregnant.
• History of allergic reaction to diphenhydramine.
• History of major psychiatric or chronic neurological disorder that would affect RLS treatment or judgment. These include but are not limited to bipolar depression, major affective disorder, schizophrenia, obsessive-compulsive disorder, and all neurodegenerative diseases.
• History of another major sleep disorder other than RLS and insomnia: narcolepsy, significant sleep-disordered breathing (DBR\>15/hr), and circadian rhythm disorder.
• History of use of dopamine antagonist within the last year for any reason other than treating nausea.
• History of use of tramadol within the last 3 months.
• Unable to give informed consent.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Richard P Allen, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate, Department of Neurology

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

US (1)