Back to resultsFeasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease (BRACELET)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep Recording
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- patient > 18 years old
- with Parkinson disease
- scheduled for implantation of electrodes for deep brain stimulation
Exclusion criteria:
- pregnant or breast feeding patient
- refusal to participate in the study
- patient under legal protection
- no health insurance coverage
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous Sleep Recording
Arm Description
Continuous Sleep Recording in Patients
Outcomes
Primary Outcome Measures
mean sleep duration per night
mean sleep onset latency
mean number of awakenings per night
Secondary Outcome Measures
Full Information
NCT ID
NCT02907723
First Posted
September 8, 2016
Last Updated
February 6, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Teva Pharmaceutical Industries, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02907723
Brief Title
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
Acronym
BRACELET
Official Title
Assessment of a Wrist Device Recording Sleep Parameters, Before and After Deep Brain Stimulation for Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Teva Pharmaceutical Industries, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This pilot study aims to assess a new device designed for an objective measure of sleep parameters. The purpose of the device is to assess, in a more simple and precise way, the impact of deep brain stimulation on patient's sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Sleep Recording
Arm Type
Experimental
Arm Description
Continuous Sleep Recording in Patients
Intervention Type
Device
Intervention Name(s)
Sleep Recording
Intervention Description
the device records movements during patients' sleep
Primary Outcome Measure Information:
Title
mean sleep duration per night
Time Frame
15 days
Title
mean sleep onset latency
Time Frame
15 days
Title
mean number of awakenings per night
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient > 18 years old
with Parkinson disease
scheduled for implantation of electrodes for deep brain stimulation
Exclusion criteria:
pregnant or breast feeding patient
refusal to participate in the study
patient under legal protection
no health insurance coverage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe BRANDEL, MD
Organizational Affiliation
Fondation OPH A de Rothschild
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
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