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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Sleep Recording

• Registration Number: NCT02907723
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Sleep Recording	Sleep Recording	Continuous Sleep Recording in Patients

Primary Outcome Measures

Name	Time	Method
mean sleep duration per night	15 days
mean sleep onset latency	15 days
mean number of awakenings per night	15 days