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

Parkinson Disease Clinical Trial

— BRACELET  

Official title:

Assessment of a Wrist Device Recording Sleep Parameters, Before and After Deep Brain Stimulation for Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907723
• Other study ID #: JBL_2014_11
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: February 6, 2018
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Sleep Recording
the device records movements during patients' sleep

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Teva Pharmaceutical Industries, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean sleep duration per night		15 days
Primary	mean sleep onset latency		15 days
Primary	mean number of awakenings per night		15 days