- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907723
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease (BRACELET)
February 6, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild
Assessment of a Wrist Device Recording Sleep Parameters, Before and After Deep Brain Stimulation for Parkinson's Disease
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Sleep Recording
Continuous Sleep Recording in Patients
|
the device records movements during patients' sleep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean sleep duration per night
Time Frame: 15 days
|
15 days
|
mean sleep onset latency
Time Frame: 15 days
|
15 days
|
mean number of awakenings per night
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jean-Philippe BRANDEL, MD, Fondation OPH A de Rothschild
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
September 8, 2016
First Submitted That Met QC Criteria
September 15, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
February 7, 2018
Last Update Submitted That Met QC Criteria
February 6, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JBL_2014_11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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