NL-OMON40474
Completed
Not Applicable
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 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructief Slaap Apneu Syndroom
- Sponsor
- Sint Lucas Andreas Ziekenhuis
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\+ 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.).
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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