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

NCT01742182 | Completed

• 2 other identifiers: Circadian Rhythms in PD1K23NS072283-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Excessive Daytime Sleepiness; Circadian Rhythms; Light Therapy

Outcome Measures

Primary Outcomes (3)

• circadian rhythm of melatonin

  June 2012- May 2017

• Sleep Efficiency

  June 2012- May 2017

• Daytime Somnolence

  June 2012- May 2017

Study Arms (4)

Control

NO INTERVENTION

PD patients without sleep problems

NO INTERVENTION

PD patients with sleep problems

ACTIVE COMPARATOR

light exposure

Other: Light exposure

PD patients with sleep problem

PLACEBO COMPARATOR

light exposure

Other: Light exposure

Interventions

Light exposure OTHER

PD patients with sleep problem; PD patients with sleep problems

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Aleksandar Videnovic, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (1)