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Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01742182
Recruitment Status : Recruiting
First Posted : December 5, 2012
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aleksandar Videnovic, MD, Northwestern University

Brief Summary:
Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Light exposure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
No Intervention: PD patients without sleep problems
Active Comparator: PD patients with sleep problems
light exposure
Other: Light exposure
Placebo Comparator: PD patients with sleep problem
light exposure
Other: Light exposure



Primary Outcome Measures :
  1. circadian rhythm of melatonin [ Time Frame: June 2012- May 2017 ]
  2. Sleep Efficiency [ Time Frame: June 2012- May 2017 ]
  3. Daytime Somnolence [ Time Frame: June 2012- May 2017 ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
  2. PD Hoehn and Yahr stage 2-4;
  3. Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
  4. Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and <10 in group 2;

Control participants will be matched for gender and age with PD participants.

Exclusion Criteria:

  1. Atypical or secondary forms of Parkinsonism;
  2. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
  3. Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
  4. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
  5. Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
  6. Use of medications known to affect melatonin secretion;
  7. Unstable/serious medical illness.

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): NCT01742182


Contacts
Contact: Laura Wulf, MA 312-503-1999 l-wulf@northwestern.edu
Contact: Karen Williams, BA 312-503-5645 k-williams8@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Aleksandar Videnovic, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Aleksandar Videnovic, MD Northwestern University

Responsible Party: Aleksandar Videnovic, MD, Assistant Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT01742182     History of Changes
Other Study ID Numbers: Circadian Rhythms in PD
1K23NS072283-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Aleksandar Videnovic, MD, Northwestern University:
Parkinson's Disease
Excessive Daytime Sleepiness
Circadian Rhythms
Light Therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases