Journal article
ENLITE PD: A Randomized Clinical Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
Movement disorders, Vol.40(11), pp.2445-2456
11/2025
DOI: 10.1002/mds.70009
PMCID: PMC13287846
PMID: 40913446
Abstract
Light therapy (LT) in Parkinson's disease improves sleep. Specific LT parameters require further study, including optimal frequency.BACKGROUNDLight therapy (LT) in Parkinson's disease improves sleep. Specific LT parameters require further study, including optimal frequency.We aimed to determine if once- or twice-daily bright white light therapy (BWLT) improves sleep. Secondary aims compared once-weekly BWLT to twice-daily dim red light therapy (DRLT) as controls, estimated effects on fatigue, and adherence.OBJECTIVESWe aimed to determine if once- or twice-daily bright white light therapy (BWLT) improves sleep. Secondary aims compared once-weekly BWLT to twice-daily dim red light therapy (DRLT) as controls, estimated effects on fatigue, and adherence.A 16-week, randomized, phase 2, sham-controlled, dose-selection trial to select the superior BWLT frequency based on change in Parkinson's Disease Sleep Scale-2 (PDSS-2), participant burden, and safety. Participants were randomized to 8 weeks of twice-daily BWLT, once-daily BWLT, once-weekly BWLT, or twice-daily DRLT. An improvement of ≥1.7 points in 8-week change of PDSS-2 by daily BWLT relative to either control warranted advancing to a phase 3 trial.METHODSA 16-week, randomized, phase 2, sham-controlled, dose-selection trial to select the superior BWLT frequency based on change in Parkinson's Disease Sleep Scale-2 (PDSS-2), participant burden, and safety. Participants were randomized to 8 weeks of twice-daily BWLT, once-daily BWLT, once-weekly BWLT, or twice-daily DRLT. An improvement of ≥1.7 points in 8-week change of PDSS-2 by daily BWLT relative to either control warranted advancing to a phase 3 trial.A total of 150 participants were randomized (mean [SD], 67 [8.6] years; 57 [38%] female; PDSS-2 17.1 [6.7]). Mean 8-week change from baseline in PDSS-2 score improved (twice-daily BWLT -2.6 [95% CI: -4.4, -0.7]; once-daily BWLT -1.5 [-3.3, 0.3]; once-weekly BWLT -0.4 [-2.2, 1.4]; twice-daily DRLT -1.8 [-3.6, 0.1]) but did not meet criteria for advancing. Mean 8-week change from baseline in Parkinson's Disease Fatigue Scale (PFS-16) score improved (twice-daily BWLT -6.4 [-9.8, -3.0]; once-daily BWLT -2.2 [-5.5, 1.1]; once-weekly BWLT -0.5 [-3.9, 2.8]; and twice-daily DRLT -3.8 [-7.3, -0.4]). Mean adherence to LT was 63%-86%.RESULTSA total of 150 participants were randomized (mean [SD], 67 [8.6] years; 57 [38%] female; PDSS-2 17.1 [6.7]). Mean 8-week change from baseline in PDSS-2 score improved (twice-daily BWLT -2.6 [95% CI: -4.4, -0.7]; once-daily BWLT -1.5 [-3.3, 0.3]; once-weekly BWLT -0.4 [-2.2, 1.4]; twice-daily DRLT -1.8 [-3.6, 0.1]) but did not meet criteria for advancing. Mean 8-week change from baseline in Parkinson's Disease Fatigue Scale (PFS-16) score improved (twice-daily BWLT -6.4 [-9.8, -3.0]; once-daily BWLT -2.2 [-5.5, 1.1]; once-weekly BWLT -0.5 [-3.9, 2.8]; and twice-daily DRLT -3.8 [-7.3, -0.4]). Mean adherence to LT was 63%-86%.ENLITE-PD did not meet the criteria for advancing daily LT to a phase 3 trial. LT was safe and well-tolerated with good adherence. Once-weekly BWLT was a non-inferior control compared with twice-daily DRLT. © 2025 International Parkinson and Movement Disorder Society. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.CONCLUSIONSENLITE-PD did not meet the criteria for advancing daily LT to a phase 3 trial. LT was safe and well-tolerated with good adherence. Once-weekly BWLT was a non-inferior control compared with twice-daily DRLT. © 2025 International Parkinson and Movement Disorder Society. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.
Details
- Title: Subtitle
- ENLITE PD: A Randomized Clinical Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
- Creators
- Aleksandar Videnovic - Mass General BrighamChristopher S Coffey - University of IowaElizabeth B Klerman - Mass General BrighamMerit Cudkowicz - Mass General BrighamHyun Joo Cho - National Institute of Neurological Disorders and StrokeAmy Amara - University of Colorado Anschutz Medical CampusKaren Marder - Columbia UniversityPhyllis Zee - Northwestern UniversityChristina Desir - Massachusetts General HospitalHolly Ernst - University of IowaErin Steinhart - Massachusetts General HospitalMichelle CostiganAnna Gudjonsdottir - University of IowaElizabeth Klingner - University of IowaDixie Ecklund - University of IowaMarianne Chase - Massachusetts General HospitalAmy Wang - Mass General BrighamDavid Charles - Vanderbilt UniversityDavid Clifford - Washington University in St. LouisJuliana Coleman - University of Alabama at BirminghamAlberto J Espay - University of CincinnatiAlbert Y Hung - Mass General BrighamSrinath Kadimi - Yale UniversityAnnie Killoran - University of Iowa, NeurologyLan Luo - Beth Israel Deaconess Medical CenterRoneil Malkani - Northwestern UniversityJason Margolesky - University of MiamiJennifer Marsella - University of RochesterCarine Maurer - Stony Brook UniversityDragos Mihaila - SUNY Upstate Medical UniversityPaolo Moretti - University of UtahAriane Park - The Ohio State UniversityNicolas Phielipp - University of California, IrvineHarini Sarva - Cornell UniversityBinit Shah - University of VirginiaHolly A Shill - Barrow Neurological InstituteAndrew Siderowf - University of PennsylvaniaValerie Suski - Pittsburg State UniversityJessica Tate - Wake Forest UniversityWinona Tse - Icahn School of Medicine at Mount SinaiKara Wyant - University of MichiganLin Zhang - University of California, DavisChristine Annis - University of RochesterKatherine Ambrogi - The Ohio State UniversityGabrielle Auerbach - Cornell UniversityMelanie Benge - University of Alabama at BirminghamEmma Blystone - SUNY Upstate Medical UniversityLoraine Brenner - University of IowaCarolina Burgos Aguilar - Wake Forest UniversityGrace Bwala - Mass General BrighamJuliana Dorsch - University of UtahErica Goude - University of California, DavisHilda Gutierrez - Beth Israel Deaconess Medical CenterKelly Harper - Vanderbilt UniversitySamuel Hochberger - Cornell UniversityPriyanka Kalyani - University of PennsylvaniaJessica Lamb - Stony Brook UniversityKay Maupin - University of VirginiaAngela Molloy - University of CincinnatiSherri Mosovsky - University of PennsylvaniaMysha Sissine - Wake Forest UniversityJulie Steele - University of MiamiMonica Szela - Northwestern UniversityMangesha Teshome - Washington University in St. LouisMarie Wencel - University of California, IrvineEric A Macklin - Mass General Brigham
- Resource Type
- Journal article
- Publication Details
- Movement disorders, Vol.40(11), pp.2445-2456
- DOI
- 10.1002/mds.70009
- PMID
- 40913446
- PMCID
- PMC13287846
- NLM abbreviation
- Mov Disord
- ISSN
- 1531-8257
- eISSN
- 1531-8257
- Publisher
- WILEY; HOBOKEN
- Grant note
The authors wish to thank the Mass General Brigham Institutional Review Board (IRB) (formerly Partners Human Research Affairs) for coordination and implementation of the single IRB model. This report does not represent the official view of the National Institutes of Health (NIH) or any part of the U.S. Federal Government. No official support or endorsement of this article by the NINDS or NIH is intended or should be inferred.
- Language
- English
- Electronic publication date
- 09/06/2025
- Date published
- 11/2025
- Academic Unit
- Neurology; Psychiatry; Biostatistics
- Record Identifier
- 9984958604502771
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