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Active, Not Recruiting

NCT Number: NCT02909192

Bright Light Therapy for Non-motor Symptoms 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. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

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: No

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
  • Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed
  • Stable dose of PD medications for at least 4 weeks prior to the study screening.

Exclusion criteria

  • Atypical or secondary forms of parkinsonism
  • Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
  • Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS
  • 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
  • Untreated hallucinations or psychosis (drug-induced or spontaneous)
  • Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed
  • Use of Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (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, such as lithium, alpha- and beta-adrenergic antagonists
  • Shift work, currently or within the prior 3 months
  • Travel through ≥ 2 time zones within 60 days prior to study screening
  • Hematocrit <32 mm3
  • Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
  • Dense cataracts
  • Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
  • Unstable/serious medical illness.
  • Pregnancy

Treatment and study plan

Light Therapy Device

Device

Primary outcomes

  1. Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality

    Time frame: 8 weeks

Secondary outcomes

  1. Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness

    Time frame: 8 weeks

  2. Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms

    Time frame: 8 weeks

  3. Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease

Important dates

Study start
2016
Primary completion
2022
Study completion
2026
First posted
Sep 21, 2016
Registry last updated
Nov 5, 2025

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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