title: Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease.
abstract: PurposeThe purpose of the study was to study the effect of an organic light-emitting diode sleep mask on daytime alertness, wellbeing, and retinal structure/function in healthy volunteers and in diabetic macular oedema (DMO).Patients and methodsHealthy volunteers in two groups, 18-30 yrs (A), 50-70 yrs (B) and people with DMO (C) wore masks (504 nm wavelength; 80 cd/m2luminance; ≤8 h) nightly for 3 months followed by a 1-month recovery period. Changes from baseline were measured for (means): psychomotor vigilance task (PVT) (number of lapses (NL), response time (RT)), sleep, depression, psychological wellbeing (PW), visual acuity, contrast sensitivity, colour, electrophysiology, microperimetry, and retinal thickness on OCT.ResultsOf 60 participants, 16 (27%) withdrew, 8 (13%) before month 1, due to sleep disturbances and mask intolerance. About 36/55 (65%) who continued beyond month 1 reported ≥1 adverse event. At month 3 mean PVT worsened in Group A (RT (7.65%, P<0.001), NL (43.3%, P=0.005)) and mean PW worsened in all groups (A 28.0%, P=0.01, B 21.2%, P=0.03, C 12.8%, P<0.05). No other clinically significant safety signal was detected. Cysts reduced/resolved in the OCT subfield of maximal pathology in 67% Group C eyes. Thinning was greater at 3 and 4 months for greater baseline thickness (central subfield P<0.001, maximal P<0.05).ConclusionSleep masks showed no major safety signal apart from a small impairment of daytime alertness and a moderate effect on wellbeing. Masks were acceptable apart from in some healthy participants. Preliminary data suggest a beneficial effect on retinal thickness in DMO. This novel therapeutic approach is ready for large clinical trials.
authors.affiliation: St Paul's Eye Unit, Royal Liverpool University Hospitals NHS Trust, Liverpool, UK.|Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
authors.forename: J N
authors.initials: JN
authors.lastname: Sahni
authors.affiliation: Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.|Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
authors.forename: G
authors.initials: G
authors.lastname: Czanner
authors.affiliation: St Paul's Eye Unit, Royal Liverpool University Hospitals NHS Trust, Liverpool, UK.
authors.forename: T
authors.initials: T
authors.lastname: Gutu
authors.affiliation: St Paul's Eye Unit, Royal Liverpool University Hospitals NHS Trust, Liverpool, UK.
authors.forename: S A
authors.initials: SA
authors.lastname: Taylor
authors.affiliation: Department of Psychological Sciences, Institute of Psychology, Health and Society, Liverpool, UK.
authors.forename: K M
authors.initials: KM
authors.lastname: Bennett
authors.affiliation: Department of Psychological Sciences, Institute of Psychology, Health and Society, Liverpool, UK.
authors.forename: S M
authors.initials: SM
authors.lastname: Wuerger
authors.affiliation: Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
authors.forename: I
authors.initials: I
authors.lastname: Grierson
authors.affiliation: Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
authors.forename: C
authors.initials: C
authors.lastname: Murray-Dunning
authors.affiliation: Polyphotonix Medical Ltd, Durham, UK.
authors.forename: M N
authors.initials: MN
authors.lastname: Holland
authors.affiliation: St Paul's Eye Unit, Royal Liverpool University Hospitals NHS Trust, Liverpool, UK.|Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
authors.forename: S P
authors.initials: SP
authors.lastname: Harding
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003118:Color Perception / Q000528:radiation effects; D015350:Contrast Sensitivity / Q000528:radiation effects; D003930:Diabetic Retinopathy / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008269:Macular Edema / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008397:Masks; D008875:Middle Aged; D017060:Patient Satisfaction; D010789:Phototherapy / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D011597:Psychomotor Performance / Q000528:radiation effects; D011930:Reaction Time / Q000528:radiation effects; D012160:Retina / Q000503:physiopathology / Q000528:radiation effects; D012890:Sleep / Q000528:radiation effects; D012893:Sleep Wake Disorders / Q000209:etiology; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields / Q000502:physiology; D055815:Young Adult