Validation of Orofacial Myofunctional Evaluation Protocol with Scores (OMES) with objective measurement of oropharyngeal muscle tone using Iowa Oral Performance Instrument (IOPI) and tongue digital spoon in severe obstructive sleep apnea hypopnea syndrome (OSAHS)

Hospital Qironsalud Marbella0 个研究点目标入组 49 人开始时间: 2021年3月24日最近更新: 2023年3月13日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34115605/ (added 14/06/2021) 2023 Results article in https://doi.org/10.1002/ohn.283 (added 27/02/2023)

•Current inclusion criteria as of 29/03/2021:
•1. Ages between 18 and 75 years
•2. Diagnosis of moderate to severe OSAHS (AHI>30) without having had previous experience of said condition and not undergoing treatment due to different circumstances
•3. Not having undergone any previous treatment for OSAHS
•4. Signed informed consent (IC) form
•1. Adequate sleep hygiene
•2. No complaints of snoring
•3. No complaints of daytime sleepiness
•4. Epworth Scale <7 points
•Previous inclusion criteria:
•1. Ages between 18 and 75 years
•2. Diagnosis of moderate to severe OSAHS (AHI>15) without having had previous experience of said condition and not undergoing treatment due to different circumstances
•3. Not having undergone any previous treatment for OSAHS
•4. Signed informed consent (IC) form
•1. Adequate sleep hygiene
•2. No complaints of snoring
•3. No complaints of daytime sleepiness
•4. Epworth Scale <7 points

•1. Cognitive or neurological deficit
•2. Inability to answer questionnaires
•3. Severe alcoholism
•4. Presence of craniofacial malformations
•5. Active neoplastic disease
•6. History of prior orofacial muscle rehabilitation therapy and any prior apnoea treatment which may modify the study results (surgery, MAD, CPAP)

发起方

Hospital Qironsalud Marbella