Analysis of the clinical effects of head positional therapy with the Sleep Position Trainer Wave in the treatment of Positional Obstructive Sleep Apnea - Sleep Position Trainer Wave for POSA patients

Sint Lucas Andreas Ziekenhuis0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•+ 18 years and older.
•+ Ability to speak, read and write the local country*s language (Dutch, French or Spanish depending on the country).
•+ Ability to follow up.
•+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
•+ Diagnosis of 10 to 90% head supine position during the night.
•+ AHI head supine is 2 > as high as AHI non-supine.
•+ AHI head and trunk supine is 2 > as high as AHI non-supine.
•+ Own a Windows PC and ability to install SPT connection software and upload research data.
•+ Expected motivation to wear the SPT Wave for 50 days.
•+ Expected to maintain current lifestyle (sports, medicine, diet etc.).
•+ Normal audiogram for both ears

•- Central Sleep Apnea Syndrome.
•- Night or shifting work.
•- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
•- Seizure disorder.
•- Known medical history of mental retardation, memory disorders or psychiatric disorders.
•- Inability to provide informed consent.
•- Simultaneous use of other treatment modalities to treat OSA.
•- Hearing loss, wearing other ear devices.
•- Anatomic ear abnormalities which influences correct attachment of the SPT Wave to the head and ear
•- BMI above 35
•- Extreme Migraine

发起方

Sint Lucas Andreas Ziekenhuis