Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT05049135
Brief Summary:
To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.
Detailed Description:
A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.
Study:
NCT05049135
Study Brief:
Protocol Section:
NCT05049135