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Nasopharyngoscopic Evaluation of MAS in Obstructive Sleep Apnoea

Researchers: Prof Stuart MacKay, Dr Andrew Jones, Dr Terry Sands, Dr Sebastian Sekulic, SueEllen Holmes

You are invited to participate in Illawarra ENT Head and Neck Clinic research aimed at documenting how your Mandibular Advancement Splint (MAS) changes the dimensions of your upper airway, as shown on fibreoptic nasopharyngoscopic examination.

Purpose of the Research:

Fibreoptic nasopharyngoscopy is a routine part of an ENT examination for individuals with Obstructive Sleep Apnea (OSA) that assesses the shape and collapsibility of the upper airway by inserting a slim video tube into the throat and recording its progress. This study will investigate whether measurements of the upper airway from fibreoptic nasopharyngoscopic images taken during the initial ENT examination can help to predict those who respond best to treatment with a MAS for their OSA. Furthermore, a Dentitrack chip in the MAS will monitor compliance, which has not been reliably confirmed in the past.

What is involved:

All aspects of your care will proceed according to standard patient treatment in consultation with Drs MacKay, Jones, Sands and Sekulic, and agreed upon by you. The use of a MAS involves an initial overnight sleep study in the laboratory to determine your Apnoea Hypopnea Index (AHI) that measures OSA severity (if you have not had one in the previous year), and a routine fibreoptic nasopharyngoscopic examination to determine level and severity of upper airway collapse. Should you agree to participate, this study aims to analyse fixed images from this video examination to assess anatomical features that may differentiate those who respond well to MAS treatment from those who do not. All personal information will be removed from still photos of the upper airway to analyse circumference, length and diameter at medically defined levels. After a period of 4-6 weeks to titrate your MAS to maximum comfort, you will undergo a second routine sleep study with the splint in place to gauge the effect on your AHI. With your permission we will compare the before and after sleep study results to see if nasopharyngoscopic images can predict patients whose AHI will drop by more than 50% (known as MAS responders).

De-identified information from four routine questionnaires completed at clinic visits before MAS fitting and after the second sleep study – on snoring, daytime sleepiness, and how your condition affects your daily life, as well as on treatment symptoms – will clarify the intervention’s impact on your health and daily living. These questionnaires take no more than half an hour and are completed at the time of each clinic visit. We will also access related demographic data such as your age, sex, BMI, and sleep study results. Any information provided by you will conform to legal obligations for privacy and confidentiality, and the storage of medical records. The information is stored at Illawarra ENT Head and Neck Clinic in a limited access, secured database system.

Who can participate:

Any adult considering MAS for relief of sleep symptoms is eligible for participant screening, which will determine if this is an appropriate treatment. Issues to consider are integrity of your teeth to tolerate the device and whether you are overweight.

Benefits and Risks:

Understanding how your airway changes while wearing a MAS will help clinicians to better tailor the most appropriate therapies for OSA patients in the future, and specifically target those individuals who benefit most from MAS treatment. Nasopharyngoscopy is a minimally invasive medical procedure conducted regularly at iENT. The risks of the procedure are low with mild discomfort and will be explained by Prof Stuart MacKay during consultation.

Those interested in the above studies can call reception at Illawarra ENT Head and Neck Clinic on 02 4226 1055 or go to website.

APPROVED HREC NUMBER ISLHD HE14/462

Sleep Health Foundation
ABN: 91 138 737 854
Suite 114, 30 Campbell Street, Blacktown, NSW, 2148
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