Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Northwestern University
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aleksandar Videnovic, Northwestern University
ClinicalTrials.gov Identifier:
NCT01742182
First received: December 3, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Parkinson's Disease
 Other: Light exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • circadian rhythm of melatonin [ Time Frame: June 2012- May 2017 ] [ Designated as safety issue: No ]
  • Sleep Efficiency [ Time Frame: June 2012- May 2017 ] [ Designated as safety issue: No ]
  • Daytime Somnolence [ Time Frame: June 2012- May 2017 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Northwestern University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Aleksandar Videnovic, MD Northwestern University
  More Information

No publications provided

Responsible Party: Aleksandar Videnovic, Assistant Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT01742182     History of Changes
Other Study ID Numbers: Circadian Rhythms in PD, 1K23NS072283-01A1
Study First Received: December 3, 2012
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board, Northwestern University

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013