Status:
COMPLETED
Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Parkinson's Disease
Tremor
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatme...
Eligibility Criteria
Inclusion
- Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
- Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
- Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score \>5) at the subject's baseline pre-surgical evaluation.
Exclusion
- Known narcolepsy
- Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
- Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.
Key Trial Info
Start Date :
July 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01169324
Start Date
July 15 2010
End Date
December 11 2015
Last Update
April 26 2019
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294