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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907723
Acronym
BRACELET
Enrollment
5
Registered
2016-09-20
Start date
2014-12-31
Completion date
2016-06-30
Last updated
2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

the device records movements during patients' sleep

Sponsors

Teva Pharmaceutical Industries, Ltd.
CollaboratorINDUSTRY
Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mean sleep duration per night15 days
mean sleep onset latency15 days
mean number of awakenings per night15 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026