Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479531
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2007-05-25
Brief Title:
Sequential Compression Devices for Treatment of Restless Legs Syndrome
Sponsor:
Walter Reed Army Medical Center
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective Randomized Sham-Controlled Study
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if sequential compression devices SCD when worn for an hour per day by patients suffering from Restless Legs Syndrome RLS are helpful for the improvement of the RLS symptoms and sleep
Detailed Description:
Restless legs syndrome RLS is a highly vexing problem manifested by sensory and motor symptoms that disrupt sleep onset or sleep maintenance RLS is the second most common sleep disorder and occurs with an estimated prevalence of 10 in the general population The sleep disruption results in daytime symptoms such as excessive daytime sleepiness EDS and mood changes There are no consistently reliable treatment alternatives There is an urgent need for new innovative treatment strategies because available pharmacological treatments often stop working over time or are associated with unacceptable side effects An effective nonpharmacological treatment would be a highly attractive alternative
Anecdotally patients have reported that use of sequential compression devices SCD prescribed for prophylaxis of deep vein thrombosis can have a positive effect on RLS symptoms Because this nonpharmacological alternative is available safe and affordable further investigation is warranted
Simply stated the null hypothesis is that SCD therapy does not have an impact on RLS symptoms
Patients will be randomized to wearing SCDs or sham SCDs for an hour each day prior to the usual onset of the RLS symptoms At baseline and at monthly follow-ups for 3 to 4 months participants will complete questionnaires to assess the severity of the RLS symptoms their daytime sleepiness and the impact of the RLS on quality of life
Anecdotally patients have reported that use of sequential compression devices SCD prescribed for prophylaxis of deep vein thrombosis can have a positive effect on RLS symptoms Because this nonpharmacological alternative is available safe and affordable further investigation is warranted
Simply stated the null hypothesis is that SCD therapy does not have an impact on RLS symptoms
Patients will be randomized to wearing SCDs or sham SCDs for an hour each day prior to the usual onset of the RLS symptoms At baseline and at monthly follow-ups for 3 to 4 months participants will complete questionnaires to assess the severity of the RLS symptoms their daytime sleepiness and the impact of the RLS on quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None