NCT02909192

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. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2016Nov 2026

First Submitted

Initial submission to the registry

September 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

5.6 years

First QC Date

September 15, 2016

Last Update Submit

November 4, 2025

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseExcessive Daytime SleepinessCircadian RhythmsLight Therapy

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (3)

  • Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness

    8 weeks

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

    8 weeks

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

    8 weeks

Study Arms (2)

Bright light therapy

ACTIVE COMPARATOR

Participants will be treated twice daily with bright light therapy.

Device: Light Therapy Device

Dim-Red light therapy

ACTIVE COMPARATOR

Participants will be treated twice daily with dim-red light therapy.

Device: Light Therapy Device

Interventions

Light Therapy DeviceDEVICE
Bright light therapyDim-Red light therapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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.

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Aleksandar Videnovic, MD, MSc

    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 Neurologist

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 21, 2016

Study Start

December 1, 2016

Primary Completion

July 5, 2022

Study Completion (Estimated)

November 1, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations

US(1)