Parkinson DiseaseNCT04291014

Light Therapy for PD - Dose Selection

A study testing SunRay Light Boxes in people with Parkinson Disease and Sleep Disorder, run by Massachusetts General Hospital at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Parkinson Disease, Sleep Disorder, Fatigue
What is being tested?: SunRay Light Boxes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 25 sitesUnited States
Study dates: 11 Sep 2020to 10 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 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 Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
PD Hoehn and Yahr stage 2-4;
A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
Stable dose of all PD medications for at least 30 days prior to randomization;
Willingness to wear an Actiwatch and complete daily sleep logs;
Age 45 or above

Who cannot join

Atypical or secondary forms of parkinsonism;
Co-existent significant sleep apnea at screening, as determined by the PI's clinical assessment; adequately treated sleep apnea, as assessed by sleep apnea machine download (CPAP download) will be permitted;
Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
Cognitive impairment as determined by a Mini Mental State Examination score <25 at screening;
Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;
Current untreated hallucinations or psychosis (drug-induced or spontaneous) with a score of 2 or above on the Hallucinations and Psychosis question of the MDS-UPDRS Part 2;

Show all 15Show fewer

Use of hypno-sedative drugs for sleep or stimulants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for Insomnia;
Use of antidepressants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
Work hours between 10 PM and 6 AM, within 60 days prior to randomization or anticipated during the 16 weeks after screening;
Travel between 3 or more time zones within 45 days prior to study screening or anticipated such travel during the 16 weeks after screening;
Unstable or serious medical illness;
History of significant eye trauma or disease, retinopathy, or cataract Grade 4 that would significantly affect transmission or processing of light through either eye;
Current use, use at any time during study participation, or use within the 30 days prior to screening of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the participant during the trial, including: amiodarone, porfimer, psoralens, chlorpromazine, quinidine, demeclocycline, temoporfin, tetracycline, fleroxacin, oral isoretinoin, voriconazole, nalidixic acid, thioridazine, St. John's wort, ofloxacin, and piroxicam;
Pregnant women will be excluded from participation; if a participant is pre-menopausal, a urine pregnancy test will be conducted at randomization to determine eligibility.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43221
Yale University
Fairfield, Connecticut, 06824
University of Iowa
Iowa City, Iowa, 52242
UC Irvine
Irvine, California, 92697
University of Miami
Miami, Florida, 33136
Vanderbilt University
Nashville, Tennessee, 37232
Weill Cornell
New York, New York, 10021
Mount Sinai - Icahn School of Medicine
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
UC Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
Washington University in St. Louis
St Louis, Missouri, 63110
SUNY Stonybrook
Stony Brook, New York, 11794
SUNY Upstate
Syracuse, New York, 13210
Wake Forest University
Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease

Read the detailed description

This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.

Conditions: Parkinson Disease, Sleep Disorder, Fatigue
Being tested: SunRay Light Boxes
Keywords: Parkinson Disease, Light therapy
Medical subject headings: Parkinson Disease, Sleep Wake Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SunRay Light BoxesDevice
SunRay light boxes will be used to administer the light therapy.

Study groups in NCT04291014
Study group	Role	What they receive
BWLT once daily	Experimental	Participants in this arm will receive bright white light therapy daily once a day (in the evening) Receives: Device: SunRay Light Boxes
BWLT twice daily	Experimental	Participants in this arm will receive bright white light therapy daily twice a day (morning and evening). Receives: Device: SunRay Light Boxes
BWLT weekly	Experimental	Participants in this arm will receive bright white light therapy once weekly (in the evening). Receives: Device: SunRay Light Boxes
DRLT twice daily	Experimental	Participants in this arm will receive dim red light twice daily (morning and evening). Receives: Device: SunRay Light Boxes

What is being measured

The primary outcome is the main question the study is designed to answer.

Parkinson's Disease Sleep Scale 2
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Measured: 8 weeks

Secondary outcomes (3)

Parkinson's Fatigue Scale 16
The Parkinson's Fatigue Scale (PFS-16) is a 16-item patient-rated scale that measures the presence of fatigue and its impact on daily function in patients with Parkinson's Disease. The scale includes seven items assessing the presence of fatigue and nine items measuring its impact on daily activities. The scoring range for the PFS-16 is from 1 to 5 (range 16-80), with higher scores indicating more severe fatigue. The scale is designed to exclude cognitive and emotional features of fatigue and is used to assess levels of fatigue and measure changes in response to treatment or lifestyle changes.
Measured: 8 weeks
Parkinson's Disease Sleep Scale 2
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Measured: 8 weeks
Adherence
The secondary objective of adherence centered on frequency of use. Participants recorded light exposure duration and timing daily using a LT log. For each prescribed active treatment dose frequency (once-daily BWLT, twice-daily BWLT), a binary measure of adherence was recorded for each expected day based on whether or not they completed LT at the correct frequency. The overall percentage of those days where participants completed LT at the correct frequency were compared between the two daily BWLT treatments using a generalized linear mixed model.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202010 Jan 2023

First posted2 Mar 2020
Study start11 Sep 2020
Primary completion12 Nov 2022
Study completion10 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Parkinson 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
Model description: This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04291014
Sponsor's protocol ID: NN110 1U01NS114001
Status last verified: Feb 2026
First submitted: 27 Feb 2020
Last updated: 5 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: This trial will follow the NINDS policy for data sharing.

Publications

Willis GL, Turner EJ. Primary and secondary features of Parkinson's disease improve with strategic exposure to bright light: a case series study. Chronobiol Int. 2007;24(3):521-37. doi: 10.1080/07420520701420717.
PubMed 17612949
Paus S, Schmitz-Hubsch T, Wullner U, Vogel A, Klockgether T, Abele M. Bright light therapy in Parkinson's disease: a pilot study. Mov Disord. 2007 Jul 30;22(10):1495-1498. doi: 10.1002/mds.21542.
PubMed 17516492
Terman M, Terman JS. Bright light therapy: side effects and benefits across the symptom spectrum. J Clin Psychiatry. 1999 Nov;60(11):799-808; quiz 809.
PubMed 10584776
Gallin PF, Terman M, Reme CE, Rafferty B, Terman JS, Burde RM. Ophthalmologic examination of patients with seasonal affective disorder, before and after bright light therapy. Am J Ophthalmol. 1995 Feb;119(2):202-10. doi: 10.1016/s0002-9394(14)73874-7.
PubMed 7832227
Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192.
PubMed 28241159
Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.
PubMed 21312275
Brown RG, Dittner A, Findley L, Wessely SC. The Parkinson fatigue scale. Parkinsonism Relat Disord. 2005 Jan;11(1):49-55. doi: 10.1016/j.parkreldis.2004.07.007.
PubMed 15619463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
ClinicalTrials.gov ID: NCT04291014
Acronym / sponsor ID: NN110 1U01NS114001
Conditions: Parkinson Disease, Sleep Disorder, Fatigue
Keywords: Parkinson Disease, Light therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 11 Sep 2020 (actual)
Primary completion: 12 Nov 2022 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 2 Mar 2020 (actual)
Results: Posted 5 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.

Arm	Type	Receives
BWLT once daily	Experimental	Device: SunRay Light BoxesParticipants in this arm will receive bright white light therapy daily once a day (in the evening)
BWLT twice daily	Experimental	Device: SunRay Light BoxesParticipants in this arm will receive bright white light therapy daily twice a day (morning and evening).
BWLT weekly	Experimental	Device: SunRay Light BoxesParticipants in this arm will receive bright white light therapy once weekly (in the evening).
DRLT twice daily	Experimental	Device: SunRay Light BoxesParticipants in this arm will receive dim red light twice daily (morning and evening).

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
PD Hoehn and Yahr stage 2-4;
A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
Stable dose of all PD medications for at least 30 days prior to randomization;
Willingness to wear an Actiwatch and complete daily sleep logs;

Key exclusion criteria (15 listed)

Atypical or secondary forms of parkinsonism;
Co-existent significant sleep apnea at screening, as determined by the PI's clinical assessment; adequately treated sleep apnea, as assessed by sleep apnea machine download (CPAP download) will be permitted;
Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
Cognitive impairment as determined by a Mini Mental State Examination score <25 at screening;
Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;

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
SunRay Light BoxesSunRay light boxes will be used to administer the light therapy.	Device	BWLT once daily, BWLT twice daily, BWLT weekly, DRLT twice daily

Primary outcome

Parkinson's Disease Sleep Scale 2
Time frame: 8 weeks
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.

3 secondary outcomes

Parkinson's Fatigue Scale 16
Time frame: 8 weeks
Parkinson's Disease Sleep Scale 2
Time frame: 8 weeks
Adherence
Time frame: 8 weeks

Results and safety

Results posted to the registry on 5 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BWLT Once Daily	37	36
BWLT Twice Daily	39	33
BWLT Weekly	37	35
DRLT Twice Daily	37	32

Primary outcome: Parkinson's Disease Sleep Scale 2

Time frame: 8 weeks. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	BWLT Once Daily n = 37	BWLT Twice Daily n = 39	BWLT Weekly n = 37	DRLT Twice Daily n = 37
Value	-1.5202 (-3.3051 to 0.2647)	-2.5692 (-4.4186 to -0.7198)	-0.408 (-2.2014 to 1.3853)	-1.7608 (-3.6150 to 0.09342)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for AEs from the time they provide informed consent until 30 days following their completion of the study (including early termination), on average for 4 months. At that point, all ongoing AEs were followed to resolution.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BWLT Once Daily	1 of 37 (2.7%)	5 of 37 (13.5%)	0 of 37
BWLT Twice Daily	0 of 39 (0%)	7 of 39 (17.9%)	0 of 39
BWLT Weekly	1 of 37 (2.7%)	4 of 37 (10.8%)	0 of 37
DRLT Twice Daily	3 of 37 (8.1%)	5 of 37 (13.5%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17612949Willis GL, Turner EJ. Primary and secondary features of Parkinson's disease improve with strategic exposure to bright light: a case series study. Chronobiol Int. 2007;24(3):521-37. doi: 10.1080/07420520701420717.
Background: PubMed 17516492Paus S, Schmitz-Hubsch T, Wullner U, Vogel A, Klockgether T, Abele M. Bright light therapy in Parkinson's disease: a pilot study. Mov Disord. 2007 Jul 30;22(10):1495-1498. doi: 10.1002/mds.21542.
Background: PubMed 10584776Terman M, Terman JS. Bright light therapy: side effects and benefits across the symptom spectrum. J Clin Psychiatry. 1999 Nov;60(11):799-808; quiz 809.
Background: PubMed 7832227Gallin PF, Terman M, Reme CE, Rafferty B, Terman JS, Burde RM. Ophthalmologic examination of patients with seasonal affective disorder, before and after bright light therapy. Am J Ophthalmol. 1995 Feb;119(2):202-10. doi: 10.1016/s0002-9394(14)73874-7.
Background: PubMed 28241159Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192.
Background: PubMed 21312275Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.
Background: PubMed 15619463Brown RG, Dittner A, Findley L, Wessely SC. The Parkinson fatigue scale. Parkinsonism Relat Disord. 2005 Jan;11(1):49-55. doi: 10.1016/j.parkreldis.2004.07.007.
Individual participant dataSharing planned: No. This trial will follow the NINDS policy for data sharing.

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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.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SunRay Light Boxes in people with Parkinson Disease and Sleep Disorder, run by Massachusetts General Hospital at 25 sites 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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?

Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 2 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291014, which also lists 7 linked publications.

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 Mar 2026.