NCT02909192Active, not recruiting
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 15 Sept 2016
- Start date
- Dec 2016
- Primary completion date
- 5 Jul 2022
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT02909192
What you commit to
- Study type: Interventional
- Planned participants: 65
- From Dec 2016 to the primary completion date, 5 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
Other illness
- 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
- Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
- Unstable/serious medical illness.
Other
- Atypical or secondary forms of parkinsonism
- Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
- Presence of depression defined as the Beck Depression Inventory (BDI) score \>14
- Hematocrit \<32 mm3
- Dense cataracts
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.