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Sleep Homeostasis in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02200887
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Salvatore Galati, Ospedale Civico, Lugano

Brief Summary:

Parkinson's disease is characterized in the advanced phases by an altered response to dopaminergic therapy for the occurrence of abnormal movements called dyskinesias, that worsens the quality of life of the patient and exposes him to comorbidities. Several data show a reduction in the amount of slow wave sleep that correlates inversely with disease duration. Since this stage of sleep is linked to mechanisms of deletion of superfluous information the investigators hypothesize that the onset of dyskinesias is related to such alteration of sleep.

-This study is aimed to investigate, by means of high-density electroencephalography (hd-EEG), the sleep and in particular the slow wave in order to clarify the relations with the development of dyskinesias.


Condition or disease
Parkinson Disease

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of Sleep Homeostasis in the Development of the L-Dopa Induced Dyskinesias in Patients With Parkinson's Disease
Study Start Date : September 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Advanced Parkinsons Disease
Polysomnogram
Parkinsons Disease with Dyskinesia
Polysomnogram
De novo Parkinsons Disease
Polysomnogram
Healthy Volunteers
Polysomnogram



Primary Outcome Measures :
  1. Slow wave sleep [ Time Frame: 1 night ]
    Percentage of total sleep classified as slow wave sleep


Secondary Outcome Measures :
  1. Amplitude of slow waves during sleep [ Time Frame: 1 Night ]
    Reduction of homeostatic synaptic plasticity during the time of sleep



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy volunteers and patients with parkinson disease
Criteria

Inclusion Criteria:

  • clinical characteristics of the patients must be according the UK (United Kingdom) Brain Bank

Exclusion Criteria:

  • anamnestic obstructive sleep apneas syndrome
  • known cognitive deterioration or with MMSE (Mini-Mental State Examination) ≤24/30
  • depression ≥ 20 of the BDI scale (Beck Depression Inventory)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200887


Locations
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Switzerland
Ospedale Regionale di Lugano
Lugano, Ticino, Switzerland, 6903
Sponsors and Collaborators
Salvatore Galati
Investigators
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Principal Investigator: Salvatore Galati, MD Ospedale Regionale di Lugano
Publications:

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Responsible Party: Salvatore Galati, MD, head of service, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier: NCT02200887    
Other Study ID Numbers: EOC-NSI.12.01
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Salvatore Galati, Ospedale Civico, Lugano:
Dyskinesia
Slow Wave Sleep
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases