Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease

NCT ID: NCT02907723

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Continuous Sleep Recording

Continuous Sleep Recording in Patients

Group Type EXPERIMENTAL

Sleep Recording

Intervention Type DEVICE

the device records movements during patients' sleep

Interventions

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Sleep Recording

the device records movements during patients' sleep

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceutical Industries, Ltd.

INDUSTRY

Sponsor Role collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe BRANDEL, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Other Identifiers

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JBL_2014_11

Identifier Type: -

Identifier Source: org_study_id

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