Status:
UNKNOWN
Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Lead Sponsor:
Ectosense NV
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Conditions:
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
Detailed Description
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a fi...
Eligibility Criteria
Inclusion
- Indication for a sleep study
Exclusion
- Mentally disabled people
- Known allergy to Plexiglas (PMMA) or other acrylates
Key Trial Info
Start Date :
June 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2019
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03385187
Start Date
June 29 2017
End Date
December 15 2019
Last Update
March 21 2019
Active Locations (1)
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1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600