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

Helse Nord-Trøndelag HF

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Somnofy® sleep monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05049135

CIV-NO-21-08-037486 (Other Identifier)

200405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

Sleep apnea group

Description:

Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy

Treatment:

Device: Somnofy® sleep monitor

Control group

Description:

partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy

Treatment:

Device: Somnofy® sleep monitor