Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT)

Royal Papworth Hospital NHS Foundation Trust0 个研究点目标入组 64 人开始时间: 2022年2月18日最近更新: 2024年5月13日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37488626/ (added 25/07/2023)

•Current inclusion criteria as of 01/05/2024:
•1. Adults with moderate to severe OSAS defined by a 4% oxygen desaturation index (4% ODI) or apnoea hypopnoea index (AHI) =15/hour
•2. An Epworth Sleepiness Scale (ESS) Score >10
•3. Auto-titrated CPAP pressure of =12 cm water
•Previous inclusion criteria:
•1. Adults with moderate to severe OSAS defined by a 4% oxygen desaturation index (4% ODI) or apnoea hypopnoea index (AHI) =15/hour
•2. An Epworth Sleepiness Scale (ESS) Score >10
•3. Auto-titrated CPAP pressure of =14 cm water

•1. Inadequate dentition or other contraindication to MAD determined by a clinician or trained CPAP provider
•2. Co-morbid sleep disorder that might affect the patient’s ability to comply with treatment or benefit from therapy, or confound the interpretation of results
•3. Unstable cardio-respiratory disease or other disorder/factor judged by the clinician to preclude trial participation due to safety concerns or significant potential to confound interpretation of results
•4. Previous MAD or CPAP use
•5. Other reason for an inability to comply with the trial protocol

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