Skip to main content
Clinical Trials/NL-OMON40474
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Sint Lucas Andreas Ziekenhuis

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

Similar Trials