Scientific measures

Results of people who have tested the SOLUNox mouthguard 



Comments on the interpretation of the measurements of devices 1+2 with pulse oximeter of Ms caroXxx in Switzerland

This concerns a patient affected by noisy snoring and who consulted a sleep specialist two years ago.
An examination in a sleep laboratory showed an apnoea/hypopnoea index (AHI) < 10/hour.
The sleep specialist advised the patient to wear a mandibular advancement orthesis, which was made by a dental technician.
The patient no longer snored, but complained (despite the orthesis being repeatedly adjusted) of experiencing a lot of discomfort when wearing the device.
In August 2010, she acquired a SOLUNOX® orthesis which she adjusted without any problems.

The patient said she experienced relaxed sleep from the first night using SOLUNOX®, and of a quality she had not experienced in a long time.

Using a MD300 pulse oximeter, the patient agreed to test (and identify) the differences during sleep:

  1. Without advancement orthesis,
  2. With orthesis custom-made by a dental technician
  3. With a custom-made SOLUNOX® orthesis.

The patient was given the oximeter and was instructed on how to use it. After it was ascertained the oximeter had been used correctly, she handed it back for analysis on 30.08.2010. When analysing the recordings, a level of SpO2 saturation at 92 was fixed as the lower value for determining an event. An event is qualified as a change of at least 4% in SpO2, over a period of at least 10 seconds. The occurrence of such event, according to general experience, is attributable to a pause in respiration.

Graph 1

1) Test without orthesis

  • Duration of recordings: 7 hours and 27 minutes.
  • Events: six (6).

There was a rather extreme desaturation which was not taken into account, as it was attributable to a sudden movement of the hand wearing the measurement device. This behaviour when wearing the measurement device is well-known.

2) Test with the mandibular advancement orthesis, custom-made by a dental technician

  • Duration of recording: 6 hours 58 minutes.
  • Event: none (0).

3) Test with “SOLUNOX®

  • Duration: 2 hours 57 minutes.
  • Event: none (0).

Device 2
Given the brevity of the first measurements using SOLUNOX®, the patient agreed to undergo a new measurement. This took place in the night from 08.09 to 09.09.2010.

  • Duration: 7 hours 58 minutes.
  • Events: none (0).

The excessive deviation in the diagram, around 3.30 am, is once again due to a sudden movement of the hand wearing the measurement device.

  1. Measurements taken with the pulse oximeter during sleep, without advancement orthesis, confirm the sleep laboratory’s previous result: the patient showed a AHI (apnoea/hypopnoea index) of less than 10/hour.
  2. The measurements taken when wearing the mandibular advancement orthesis, whether this was the custom-made orthesis or the SOLUNOX® orthesis, did not reveal there to be any apnoea/hypopnoea incidents.
  3. However, self-reports from patients confirm that the custom-made “SOLUNOX®” orthesis is much more comfortable than the deep –grooved orthesis made by the dental laboratory.

If we are also to compare the significant investment in time and labour (and therefore the subsequent costs) for an orthesis made in a laboratory (in this case, €800), with the ease of use provided by SOLUNOX® and its low cost…

We will leave you to draw your own conclusions.

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