NCT02907723

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

September 8, 2016

Last Update Submit

February 6, 2018

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • mean sleep duration per night

    15 days

  • mean sleep onset latency

    15 days

  • mean number of awakenings per night

    15 days

Study Arms (1)

Continuous Sleep Recording

EXPERIMENTAL

Continuous Sleep Recording in Patients

Device: Sleep Recording

Interventions

Sleep RecordingDEVICE

the device records movements during patients' sleep

Continuous Sleep Recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jean-Philippe BRANDEL, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 20, 2016

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 7, 2018

Record last verified: 2018-02