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Completed

NCT Number: NCT01742182

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disorders of Excessive Somnolence Dyssomnias Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders Synucleinopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

light exposure

Other

Primary outcomes

  1. circadian rhythm of melatonin

    Time frame: June 2012- May 2017

  2. Sleep Efficiency

    Time frame: June 2012- May 2017

  3. Daytime Somnolence

    Time frame: June 2012- May 2017

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2012
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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