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

NCT ID: NCT05049135

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-03-07

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Sleep apnea group

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

Somnofy® sleep monitor

Intervention Type: DEVICE

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)

Control group

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

Somnofy® sleep monitor

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

Respiratory polygraphy (NOXT3, ResMed AS)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

VitalThings

INDUSTRY

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øystein Risa, PhD

Role: STUDY_DIRECTOR

NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging

Carl Platou, MD

Role: STUDY_DIRECTOR

North Trøndelag Hospital Trust

Locations

Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust

Levanger, , Norway

Countries

Norway

Other Identifiers

CIV-NO-21-08-037486

Identifier Type: OTHER

Identifier Source: secondary_id

200405

Identifier Type: -

Identifier Source: org_study_id