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

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Somnofy® sleep monitor

• Registration Number: NCT05049135
• Lead Sponsor: Helse Nord-Trøndelag HF

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Primary Completion: 2022-12-31
• Status Verified: 2023-03
• Study Completion: 2023-03-07
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleep apnea group	Somnofy® sleep monitor	Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy
Control group	Somnofy® sleep monitor	partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy

Primary Outcome Measures

Name	Time	Method
Apnea/hypopnea index	72 hours	Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep

Secondary Outcome Measures

Name	Time	Method
Sleep score	12 weeks	Objective (AI-based) score of sleep quality from raw data from sleep monitor

Trial Locations

Locations (1)

Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust; 🇳🇴 Levanger, Norway