CClinicalTrials.gg
CompletedNCT02907723BRACELETUpdated Feb 7, 2018

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

An interventional study of Sleep Recording in Parkinson Disease, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2014, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient > 18 years old
  • with Parkinson disease
  • scheduled for implantation of electrodes for deep brain stimulation

Exclusion criteria

Exclusion criteria:

  • pregnant or breast feeding patient
  • refusal to participate in the study
  • patient under legal protection
  • no health insurance coverage
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Continuous Sleep Recording

    Continuous Sleep Recording in Patients

    Device: Sleep Recording

Interventions

  • DeviceSleep Recording

    the device records movements during patients' sleep

06

What researchers measure

Primary outcomes

  1. mean sleep duration per night

    Time frame: 15 days

  2. mean sleep onset latency

    Time frame: 15 days

  3. mean number of awakenings per night

    Time frame: 15 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02907723
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Teva Pharmaceutical Industries, Ltd.
Responsible party
Sponsor
First posted
Sep 20, 2016
Start date
Dec 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Feb 7, 2018

Study contacts

Jean-Philippe BRANDEL, MD
principal investigator · Fondation OPH A de Rothschild

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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