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

February 15, 2020 updated by: Aleksandar Videnovic, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
circadian rhythm of melatonin
Time Frame: June 2012- May 2017
June 2012- May 2017
Sleep Efficiency
Time Frame: June 2012- May 2017
June 2012- May 2017
Daytime Somnolence
Time Frame: June 2012- May 2017
June 2012- May 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Circadian Rhythms in PD
  • 1K23NS072283-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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