Elsherbiny, Momen Zaky Elsayed
(2016)
The Effectiveness Of Oral Appliance In Comparison With Continuous Positive Airway Pressure In The Treatment Of Obstructive Sleep Apnoea: A Randomised Clinical Trial.
Masters thesis, Universiti Sains Malaysia.
Abstract
Satu kajian klinikal rawak berbentuk selari telah dijalankan di Institut Perubatan & Pergigian Termaju (IPPT) Universiti Sains Malaysia (USM) untuk menentukan keberkesanan aplians oral (OA) berbanding dengan tekanan udara positif berterusan (CPAP) dalam rawatan apnoea tidur obstruktif. Pesakit yang dirujuk dari Klinik Telinga, Hidung & Tekak telah disaring untuk kelayakan menyertai kajian. Selepas mengambilkira semua kriteria kemasukan dan pengecualian, seramai 40 orang pesakit telah diambil dan dibahagikan secara rawak kepada dua kumpulan rawatan; 19 orang pesakit dalam kumpulan CPAP dan 21 pesakit dalam kumpulan OA. Namun, seorang orang pesakit daripada setiap kumpulan tidak meneruskan kajian, menjadikan jumlah keseluruhan peserta kajian seramai hanya 38 orang, 18 orang pesakit dalam kumpulan CPAP dan 20 pesakit dalam kumpulan OA. Ujikaji telah mengambil masa selama sebulan yang mana Indeks Apnoea/Hypopnea, ketepuan oksigen nokturnal minima (MinO2) dan ketepuan oksigen purata (MeanO2) telah direkodkan sebelum dan selepas rawatan bagi kedua-dua kumpulan pesakit dengan menggunakan polisomnografi sepanjang malam. Skala Mengantuk Epworth (ESS) dan Indeks Kualiti Kehidupan Apnoea Tidur Calgary (SAQLI) versi Bahasa Melayu telah diberikan kepada pesakit sebelum dan selepas rawatan, masing-masing untuk menilai perubahan-perubahan dari segi rasa mengantuk pesakit pada siang hari serta kualiti kehidupan yang berhubungkait dengan kesihatan.
A parallel design randomised controlled trial was conducted at the Advanced Medical and Dental Institute (AMDI) Universiti Sains Malaysia (USM) to determine the effectiveness of oral appliances (OA) in comparison to the continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnoea. Patients referred from the Ear, Nose and Throat clinic were screened for eligibility to participate in the trial. After considering all the inclusion and exclusion criteria, 40 patients were recruited and were randomised by an online randomization software available on (www.randomization.com) which was used to produce a randomization plan. This trial was blinded and patients were randomised into two groups by a nurse opening a sealed envelope that had been prepared earlier by the researcher which contained either the letter A or B. As a result 19 patients in the CPAP group and 21 patients in the OA group were recruited. However, 1 patient from each group did not continue the trial, leaving only 38 study participants in total, 18 patients in the CPAP group and 20 patients in the OA group. The trial period was one month. Apnoea/Hypopnea index (AHI), minimum nocturnal oxygen saturation (MinO2) and mean oxygen saturation (MeanO2) were recorded before and after treatment for patients in both groups by overnight polysomnography. Epworth Sleepiness Scale (ESS) and the Malay version of Calgary Sleep Apnoea Quality of Life Index (SAQLI) were given to the patients before and after treatment to assess the changes in patient’s daytime sleepiness and health-related quality of life respectively.
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