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Completed

NCT Number: NCT05049135

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust

Levanger, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somnofy® sleep monitor

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)

Other names: Respiratory polygraphy (NOXT3, ResMed AS)

Primary outcomes

  1. Apnea/hypopnea index

    Time frame: 72 hours

    Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep

Secondary outcomes

  1. Sleep score

    Time frame: 12 weeks

    Objective (AI-based) score of sleep quality from raw data from sleep monitor

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Norwegian University of Science and Technology
  • VitalThings

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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