Feasibility of Continuous Sleep Recording in Patients Undergoing 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Recording

Device

the device records movements during patients' sleep

Primary outcomes

mean sleep duration per night

Time frame: 15 days
mean sleep onset latency

Time frame: 15 days
mean number of awakenings per night

Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

Teva Pharmaceutical Industries, Ltd.

Registry information

Official study title

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

Acronym: BRACELET

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 20, 2016
Registry last updated: Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed