Simple, non-invasive new treatment for those with sleeping woes

SINGAPORE - Madam Hamidah Bee Kadir Maideen snored so badly her husband complained he could not get a good night's sleep.

So when she was prescribed a breathing mask, she thought she had a solution to the obstructive sleep apnoea that had created her problem.

But the 55-year-old accounts administrator did not last a week with the breathing mask. "I felt like an astronaut. I couldn't breathe properly... and I couldn't turn in my sleep."

For the last three months, however, the couple have had better sleep with a new device called Provent. Provent is small, simple to use and discreet. Best of all, no mask is needed.

However, doctors here have their reservations, one of them being that there are no studies on the long-term results of using it.

People with obstructive sleep apnoea can stop breathing for 10 seconds or more during sleep, when the muscles that keep the airway open relax and cause it to collapse.

These breathing pauses can happen many times in an hour, disrupting sleep and affecting health.

In Singapore, about 15 per cent of the population is affected.

While there are various sleep apnoea solutions, the standard treatment remains a cumbersome breathing mask that sufferers strap on at night. The mask is attached to a machine, which pushes air into the nasal passages, making it easy to breathe.

This continuous positive airway pressure (CPAP) treatment is effective but it is not easy to get used to sleeping with a mask and many sufferers still do without it. Ventus Medical, the company behind Provent, is touting its product as an alternative or supplement to CPAP.

How it works

How it works

Provent is a disposable device with a small one-way valve that is held in place over the nostrils by an adhesive band.

It allows the user to breathe in easily, but not the other way around.

It works its magic by using the patient's own breathing to create pressure during exhalation.

The valve closes during exhalation so that pressure will build up within the airway, keeping it open and preventing the stoppage of breathing.

Provent is distributed here by Malaysian firm Somnotec and is available only by prescription.

Dr Tan Yoke Khim from Respiratory & Medical Specialists, who has prescribed it, said patients have to get used to the device.

Dr Kenny Pang, an ear, nose and throat surgeon at Asia Sleep Centre, added: "The resistance during exhalation may cause discomfort and result in the patient opening the mouth but when this happens, the pressure comes out and Provent might not be efficacious."

Improved sleep quality

What Madam Hamidah does is to consciously keep her mouth closed.

"It's difficult when you exhale but I don't want to use my mouth. So I will breathe out hard. Once I fall asleep, I don't feel it."

She started using Provent from February when it was available here.

"With Provent, my husband says that I don't snore so much and sometimes I don't snore at all. When I wake up in the morning, I feel very good," she said.

A set of Provent devices, individually packed, costs $5. A patient usually uses one set a day, so the cost can add up to $150 a month. The CPAP treatment, on the other hand, can cost $2,000 to $5,000 per set.

Founded by a Stanford physician Rajiv Doshi, Provent was developed by Ventus Medical, whose assets were recently acquired by Theravent in the United States.

In 2011, Ventus Medical subsidised a study of 250 patients with obstructive sleep apnoea and found that those who used Provent over a three-month period saw their breathing pauses fall by 52.7 per cent, compared with 7.3 per cent in the group that used a placebo device.

Furthermore, those using Provent showed improved alertness and a high rate of compliance, with the device being worn all night for 88.2 per cent of the nights in the study.

The study was published in the April 2011 issue of the peer-reviewed medical journal Sleep, an official publication of the American Academy of Sleep Medicine.

A follow-up study was done on the same subjects over a 12-month period and showed similar results.

"But its full effectiveness is still under study," said Dr Pang.

Provent Therapy was cleared for marketing by the US Food and Drug Administration in 2008.

It has also been approved for use by the Health Sciences Authority here.

Dr Pang's main concern is the risk of re-breathing exhaled air, as Provent is a one-way valve.

When the person breathes, he will inhale oxygen in the air but there is a chance of carbon dioxide accumulating in the airway after a while. "When you breathe your own exhaled air, you will accumulate a lot of carbon dioxide in your blood and that is not good," said Dr Pang.

"You might get headaches, higher blood pressure, fatigue and other long-term heart issues."

As the long-term results of using Provent are not available, Dr Pang said he will be conducting some studies overseas, likely in Canada, on the efficacy of this device.

Dr Tan said she would welcome more studies, noting: "It's a great idea as it's something simple, easy to use and hygienic but we still need further data to validate its efficacy especially for the more severe cases.

"The gold standard of therapy with CPAP still applies, and patients should be recommended Provent only when CPAP fails or when the condition is mild."

As for Madam Hamidah, she will not be using Provent forever. She has opted for nasal surgery as "no one wants to see their partner with something stuck in their nostrils".

joyceteo@sph.com.sg


Get a copy of Mind Your Body, The Straits Times or go to straitstimes.com for more stories.

VIDEOS TO WATCH

SERVICES