Parkinson's DiseaseNCT02909192
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
A study testing Light Therapy Device in people with Parkinson's Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Light Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Bright Light Modulation of 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.
- Conditions
- Parkinson's Disease
- Being tested
- Light Therapy Device
- Keywords
- Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Therapy DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Bright light therapy | Active comparator | Participants will be treated twice daily with bright light therapy. Receives: Device: Light Therapy Device |
| Dim-Red light therapy | Active comparator | Participants will be treated twice daily with dim-red light therapy. Receives: Device: Light Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality
Measured: 8 weeks
Secondary outcomes (3)
Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness
Measured: 8 weeks
Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms
Measured: 8 weeks
Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion5 Jul 2022
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandar Videnovic, MD, Massachusetts General Hospital
- Investigators
- Aleksandar Videnovic, MD, MSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909192
- Sponsor's protocol ID
- 2016P001775
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2016
- Last updated
- 5 Nov 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02909192
- Acronym / sponsor ID
- 2016P001775
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy | Active comparator | Device: Light Therapy DeviceParticipants will be treated twice daily with bright light therapy. |
| Dim-Red light therapy | Active comparator | Device: Light Therapy DeviceParticipants will be treated twice daily with dim-red light therapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Therapy Device | Device | Bright light therapy, Dim-Red light therapy |
Primary outcome
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality
Time frame: 8 weeks
3 secondary outcomes
Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness
Time frame: 8 weeks
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
Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandar Videnovic, MD, MSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy Device in people with Parkinson's Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.