Status:
UNKNOWN
Evaluation of the Frequency and Severity of Sleep Abnormalities in Patients With Parkinson's Disease
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Parkinson Disease
GBA Gene Mutation
Eligibility:
All Genders
50-80 years
Phase:
NA
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 ...
Detailed Description
Background 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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04387812
Start Date
June 1 2020
End Date
December 31 2024
Last Update
March 10 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tel Aviv Sourasky Medical Center, Neurology Department
Tel Aviv, Israel, 6423906