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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01742182
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 70
• Location: 1
• Arms: 4
• Actual Duration (Months): 72
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Other: Light exposure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 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
• Actual Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. circadian rhythm of melatonin [June 2012- May 2017]

2. Sleep Efficiency [June 2012- May 2017]

3. Daytime Somnolence [June 2012- May 2017]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Aleksandar Videnovic, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aleksandar Videnovic, MD, Assistant Professor of Neurology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01742182
• Other Study ID Numbers: Circadian Rhythms in PD; 1K23NS072283-01A1
• First Posted: Dec 5, 2012
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Aleksandar Videnovic, MD, Assistant Professor of Neurology, Massachusetts General Hospital: Parkinson's Disease; Excessive Daytime Sleepiness; Circadian Rhythms; Light Therapy
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Feb 18, 2020