Back to resultsCircadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light exposure
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
- PD Hoehn and Yahr stage 2-4;
- Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
- 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:
- Atypical or secondary forms of Parkinsonism;
- Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
- Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
- 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;
- Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
- Use of medications known to affect melatonin secretion;
- Unstable/serious medical illness.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Active Comparator
Placebo Comparator
Arm Label
Control
PD patients without sleep problems
PD patients with sleep problems
PD patients with sleep problem
Arm Description
light exposure
light exposure
Outcomes
Primary Outcome Measures
circadian rhythm of melatonin
Sleep Efficiency
Daytime Somnolence
Secondary Outcome Measures
Full Information
NCT ID
NCT01742182
First Posted
December 3, 2012
Last Updated
February 15, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT01742182
Brief Title
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Official Title
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
PD patients without sleep problems
Arm Type
No Intervention
Arm Title
PD patients with sleep problems
Arm Type
Active Comparator
Arm Description
light exposure
Arm Title
PD patients with sleep problem
Arm Type
Placebo Comparator
Arm Description
light exposure
Intervention Type
Other
Intervention Name(s)
Light exposure
Primary Outcome Measure Information:
Title
circadian rhythm of melatonin
Time Frame
June 2012- May 2017
Title
Sleep Efficiency
Time Frame
June 2012- May 2017
Title
Daytime Somnolence
Time Frame
June 2012- May 2017
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
PD Hoehn and Yahr stage 2-4;
Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
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:
Atypical or secondary forms of Parkinsonism;
Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
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;
Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
Use of medications known to affect melatonin secretion;
Unstable/serious medical illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar Videnovic, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
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