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

NCT04387812 | Unknown

• 1 other identifier: TASMC-20-NG-336-CTIL
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in sleep architecture

  Frequency of RBD and severity of sleep interruptions

  From placing the system to disassembling, up to 1 week

Secondary Outcomes (4)

• MDS-UPDRS

  Immediate after disassembling the system (day 7)

• REM Sleep Behavior Disorder Screening Questionnaire

  Immediate after disassembling the system (day 7)

• The Non-Motor Scale

  Immediate after disassembling the system (day 7)

• Geriatric Depression Scale

  Immediate after disassembling the system (day 7)

Study Arms (1)

Xtrodes home PSG system

EXPERIMENTAL

Wireless wearable system incorporates EEG, electrooculography (EOG) and EMG recordings over multiple nights in the home environment. The electrodes are printed on a thin sticker. These printed electrodes are marked by their conformity with the skin, light weight, ease of placement on the skin, and user comfort. The sleep-specific electrode array includes two surface EMG (electrodes 1 and 2), two EOG (electrodes 3 and 4) and four forehead EEG electrodes (electrodes 5-8) .

Device: Xtrodes home PSG system

Interventions

Xtrodes home PSG system DEVICE

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

Also known as: Home PSG system

Xtrodes home PSG system

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD (according to UK brain bank or Gelb criteria)
• Hohen and Yahr stages I-IV
• Age between 50-80
• First-degree healthy relatives, carriers of mutations in the LRRK2 and GBA genes
• Healthy volunteers
• Healthy subjects with confirmed RBD
• For patients with PD: only if they have a care partner at home who will be able to assist with the application of the technology
• Willing and able to sign an informed consent

You may not qualify if:

• Any neurological condition other than PD (e.g. Stroke, MSA, parkinsonism)
• Severe cognitive impairment (MoCA\<24)
• Psychiatric disorders
• Low back pain or any orthopaedic problem or pain that will prevent the subject from sleeping in the sleep lab or wearing the wearable sensors
• For men: a beard (because of the tattoo adhesion

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center, Neurology Department

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Anat Mirelman, PhD

  Laboratory of Early Markers of Neurodegeneration (LEMON), TASMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Mirelman, PhD

CONTACT

97236973960; anatmi@tlvmc.gov.il

Liat Yahimovich

CONTACT

97236973960; Liatya@tlvmc.gov.il

Study Design

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

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

IL (1)