Noctura 400 Sleep Mask for diabetic retinopathy and diabetic macular oedema

Level of innovation

All commentators thought that Noctura 400 Sleep Mask was a novel technology, and 1 highlighted that there was no other treatment available for DR that used this approach. One commentator emphasised that the mask would be used as an add-on therapy for DR, including macular oedema, but could also have a role in preventing the progression of DR. One commentator noted that the mask represented a potentially significant contribution to existing management of patients with pre-clinical or established DR and/or DMO but the precise levels of benefit and patient populations in which the mask should be used were yet to be established.

Potential patient impact

All 3 commentators remarked that the mask has the potential to generate significant benefits to non-proliferative DR to stop progression and the subsequent loss of vision. One commentator added that the mask may benefit patients with proliferative DR and/or DMO but more evidence of benefit is needed. Two commentators stated that the mask would be particularly beneficial for people under 65 as they may have mild, non-proliferative DR. One commentator highlighted that use of the mask should not replace good diabetic control as this is necessary to reduce the risk of complications.

One commentator noted that patients would need to be compliant in order to see the progression of the condition slowed. If that were to happen, fewer hospital visits and invasive treatments (for example, photocoagulation) would be needed. A second commentator added that if use of Noctura 400 led to a reduction in invasive treatments (for example anti-VEGF injections) this would significantly reduce the burden on patients and could lead to improved visual outcomes. The commentator agreed that using the mask could potentially significantly reduce the number of hospital visits needed.

Potential system impact

Two commentators stated that use of the mask would likely have a positive effect on NHS services by reducing the number of people referred to hospitals and the number of treatments for progressive DR.

The commentators thought that some changes to NHS facilities may be needed. Two commentators noted that a monitoring system would be necessary, and suggested that this could be done through virtual clinics and digital surveillance services, which are already set-up in some centres. One commentator suggested that minor changes to process would be needed to provide patients with training on using the mask and discussing the importance of compliance. They added that a system for disposing of the mask and its batteries would also be needed. Another commentator thought that use of the mask could be integrated into present infrastructure very easily as the mask could either be incorporated into the current diabetic screening programme or could be managed by hospital services when patients were attending clinics. The specialist suggested that, depending on the numbers of prescriptions, extra staff may be needed to programme the masks, although they would expect this to be done by the company.

One commentator highlighted that the mask would lead to cost savings if it was effective, which they believed had not been shown yet. Another thought that it was difficult to evaluate the potential cost savings with no significant trials or cost-effectiveness information available.

General comments

Two of the specialists highlighted the potential of the Noctura 400 Sleep Mask, if it is proven to be effective, to transform current management of DR and DMO. The results of the ongoing CLEOPATRA and CANDLE studies are needed before further decisions on the potential use of the mask in clinical practice are made. They added that the concerns over potential sleep deprivation and effects on psychomotor vigilance tasks - such as the speed at which people respond to stimuli - and psychosocial wellbeing needed further investigation.

One commentator remarked that the mask hasn't been evaluated in late-stage proliferative DR so it may not be clinically effective in that group. One commentator noted positive feedback from a small number of people with DR who could self-fund the mask.