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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Somnofy® sleep monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea able to sign an informed consent Exclusion Criteria: Pregnancy Serious disease which could affect ability to complete the study Complicated sleep disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleep apnea group<br>Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy | Device: Somnofy® sleep monitor<br>* 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)<br>* Other names: Respiratory polygraphy (NOXT3, ResMed AS);|
| Control group<br>partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy | Device: Somnofy® sleep monitor<br>* 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)<br>* Other names: Respiratory polygraphy (NOXT3, ResMed AS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea/hypopnea index | Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep score | Objective (AI-based) score of sleep quality from raw data from sleep monitor | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep monitor