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Evaluation of the Frequency and Severity of Sleep Abnormalities in Patients With Parkinson's Disease

NCT04387812 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-03-10

No results posted yet for this study

Summary

Sleep disturbances are one of the most common non-motor symptoms in PD, with an estimated prevalence as high as 40-90%. Sleep disturbances (particularly sleep duration, sleep fragmentation, Rapid Eye Movement (REM) sleep behavior disorder and sleep-disordered breathing) have been associated with an increased risk of neurodegeneration and are an independent risk for cognitive decline and dementia in PD.

Although much is currently unknown about sleep changes in PD, sleep-related symptoms are increasingly recognized as a major contributor to disease burden and reduced quality of life among people with PD. The "gold standard" evaluation of nocturnal sleep is polysomnographic monitoring (PSG).

This study proposes to use novel wireless skin electrodes and wearable sensors to provide a "home PSG test" incorporating several physiologic recordings, over multiple nights in the person's home, enabling the objective evaluation of night-to-night fluctuations.

Conditions

  • Parkinson Disease
  • GBA Gene Mutation
  • Leucine-rich Repeat Kinase 2 (LRRK2) Gene Mutation

Interventions

DEVICE

Xtrodes home PSG system

Wireless, convenient and relies on actual recording of EMG, EOG and EEG in a home setting

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Anat Mirelman, PhD · Laboratory of Early Markers of Neurodegeneration (LEMON), TASMC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04387812 on ClinicalTrials.gov