Win the snore wars – with a titanium ‘tulip’ up your nose

HEAVY snorers – and their long-suffering partners – have been given hope by a titanium tulip-shaped implant for the nose. The metal mesh device is inserted at night and opens up like the petal of a flower to prop open the airway while the wearer is asleep. It is then removed each morning.

Alaxo Stent is also suitable for sufferers of obstructive sleep apnoea, a more extreme manifestation of the problem in which breathing stops for short periods.

At night, the soft tissues of the back of the mouth, nose and throat relax and may narrow. Snoring is caused by these tissues vibrating during breathing. It is estimated that a third of men and almost one in ten women are regular snorers.

The noises can also be a sign of obstructive sleep apnoea or OSA, which is estimated to affect around four per cent of middle-aged men and women.

In OSA the airways close completely, blocking the flow of air into the lungs during sleep for more than ten seconds and up to more than two minutes at a time. Left untreated, OSA can increase the risk of high blood pressure, heart attack, stroke, and type 2 diabetes.

Risk factors for snoring and for OSA include being overweight, alcohol use, being over 40, having a large neck, using some medications including sleeping pills, smoking, and being menopausal, where hormonal changes can lead to throat muscles relaxing.

OSA is also three times more common in those with diabetes, and twice as likely in those who suffer with chronic nasal congestion. Treatments range from lifestyle changes, such as losing weight and stopping smoking, to soft tissue implants and surgery.

CONTINUOUS positive airway pressure or CPAP, which involves using a device to assist with breathing during sleep, is considered one of the most effective therapies for moderate to severe OSA. It involves wearing a mask over the nose to deliver a continuous supply of compressed air during sleep to prevent the airway from closing.

Although effective, it has been estimated that between 25 and 50 per cent of patients are unable to use them long term. Some find the mask difficult to get used to, while some have problems with the noise of the CPAP pump.

Unlike CPAP, the Alaxo Stent does not require a pump or electrical supply, and the wearer can move around with it in place. The device consists of a 160mm piece of braid or mesh made from nitinol, an alloy of nickel and titanium that springs back into shape after being handled.

The braid comes in a long, 4mm-wide flexible tube which the patient inserts into a nostril and pushes through the nasal cavity and into the throat while lying down. After the tube is pushed into the airway, the user retracts it, leaving just the mesh in place.

Once out of the tube, the mesh returns to its pre-formed size and shape, and the end in the throat expands like a tulip flower to become 17mm wide, thus preventing the surrounding soft tissue from collapsing.

The end of the braid protruding from the nose is taped to the cheek of the user, and in the morning, the patient simply pulls the mesh out of the nose. The developers say the challenge of insertion is no greater than that of putting a contact lens into the eye.

A study at the ENT University Hospital of Erlangen, Germany, also found that the new method worked as well as CPAP therapy.

If nasal congestion is the reason for problem breathing, another shorter device – the Alaxo Lito Nasal Stent – is designed to keep open the nasal airways alone.

It has also been shown that it increases air flow by 47 per cent in healthy volunteers, raising the possibility of other uses.

TESTING of the technology during jogging, cross-country skiing and mountain hiking suggests that it could improve breathing through the nose and sports performance.

According to researchers, breathing through the nose increases the blood oxygen content by 10 to 15 per cent compared with breathing through the mouth.

Both devices are approved for use with patients in the European Union, Canada and India.

Bhik Kotecha, a snoring specialist and a consultant ENT surgeon at the Royal National Throat, Nose & Ear Hospital in London and at Queen’s Hospital in Romford, Essex, has used the device on some of the first British patients. ‘It is approved for use i n the UK and we now have the results from a study involving our first ten cases,’ he says. ‘We found it was very effective for some patients, especially those whose snoring involves vibration of the soft palate. It is less suitable for patients where snoring is due to the collapse of the tongue base or for very severe OSA. ‘This device is a useful addition because while CPAP is the gold-standard treatment, compliance is variable, and the results from surgery are not always predictable, so that any benefits are not necessarily sustained.’

Chris Challis, a 40-year old software engineer, who lives with his wife Steph in Cambridge, was one of the first people to have the stent in the UK.

‘Having tried mouthguards and being prescribed CPAP, I found that the stent is the best, quietest and most comfortable of all the options available,’ he says.

‘CPAP was very noisy and was worse to live with than the snoring, according to my wife, plus it is not portable. I enjoy camping and going to festivals but I couldn’t take CPAP with me to them.

‘It was also very uncomfortable and my wife hated it. The mouthguards I’ve tried all tend to fall out during the night or move enough to cease being effective by the early hours of the morning, which is when Steph would most likely wake up.

‘Initially it was a tough learning curve – inserting something through your nostril every night is not the most pleasant of experiences – but it is worth it. I can now insert it without a mirror.

‘The stent has provided both of us with more undisturbed nights of sleep than all the other methods combined.’

There are several surgical techniques to correct snoring, although these are not usually available on the NHS.

However, these are only effective on a specific cause of snoring – when the problem lies with the soft tissues at the back of the mouth.

One option is for surgeons to use a blade or laser to trim away the uvula – the piece of tissue that hangs from the roof of the mouth.

The laser option is thought to be less risky in terms of bleeding and post-operative i nfection, although there is evidence that it is less effective.