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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Somnofy® sleep monitor

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

• Study Contact: Name: Hanne Sorger, md phd; Phone Number: +4791816787; Email: hanne.sorger@ntnu.no
• Study Contact Backup: Name: Vigdis Fossland; Phone Number: +74098361; Email: vigdis.fossland@hnt.no

Study Locations

• Norway
  • Levanger, Norway
    • Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleep apnea group; Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy	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); Other Names: Respiratory polygraphy (NOXT3, ResMed AS)
Control group; partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy	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); Other Names: Respiratory polygraphy (NOXT3, ResMed AS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Norwegian University of Science and Technology; VitalThings AS
• Investigators: Study Director: Øystein Risa, phd, NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging; Study Director: Carl Platou, MD, North Trøndelag Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: sleep monitor
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 200405; CIV-NO-21-08-037486 (Other Identifier: Eudamed)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No