Safety and acceptability of an organic light emitting diode (OLED) sleep mask for the treatment of retinal diseases: INSIGHT Study

Abstract

 

Purpose

 

Preventing dark adaptation by delivering low dose light during sleep is a new approach to the treatment of diseases associated with hypoxia such as diabetic maculopathy. We studied the safety of overnight use of an OLED sleep mask on psychomotor vigilance, psychological well-being and retinal structure/function in healthy volunteers.

 

Methods

 

Masks emitting light with a luminance of 80cd/m² and a peak at 504nm were developed for selective activation of rods up to a maximum of 8 hours during sleep (Figure). Participants were recruited into a single-centre prospective interventional study in 2 groups: group A 18-30 yrs, group B 50-70 yrs. The mask was worn over closed lids each night for 3 months followed by a recovery period of 1 month. Mean changes from baseline were measured for: psychomotor vigilance task (PVT) (number of lapses (NL), response time (RT)), Karolinska sleepiness scale, Pittsburgh sleep quality, depression index, best corrected visual acuity and contrast sensitivity, Cambridge colour vision (CCT), multifocal electroretinogram, electrooculogram, microperimetry and OCT central subfield thickness.

 

Results

 

Of 45 participants (21 group A, 24 group B), 11 (24%) withdrew, 5 (11%) before month 1. Reasons for withdrawal where given were sleep disturbances and mask intolerance. 30 of 40 (75%) who continued beyond month 1 reported some adverse events, mainly associated with mask discomfort or ocular symptoms. No serious adverse events occurred. Total mean mask wear in hours was lower in group A than in group B (p<0.001). At month 3, there were increases in PVT RT (group A p<0.001, group B p=0.02), PVT NL (group A p=0.005) and a decrease in CCT for deutan (group B p=0.01). At month 4, the reduction in PVT RT lessened but persisted (group A p=0.005, group B p=0.01). No significant safety signal was detected for any other outcome studied.

 

Conclusions

 

OLED sleep masks showed no significant safety signal apart from an impairment of vigilance tasks for which the effect size was small. Sleep disturbance and light intolerance tended to cause early withdrawal. Mask and ocular discomfort were commonly reported but tended to be tolerable and not to affect mask wear. Mask usage was higher in older people. These data allow improvements in mask design and dosage and planning for future clinical trials including safety advice on tasks requiring high levels of vigilance.