NCT05049135

Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.

Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Helse Nord-Trøndelag HF · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Somnofy® sleep monitor	Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP)

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-31
• Completion: 2023-03-07
• First posted: 2021-09-17
• Last updated: 2023-03-20

Locations

1 site across 1 country: Norway