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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049135
• Other study ID #: 200405
• Secondary ID: CIV-NO-21-08-037
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: March 7, 2023

Study information

• Verified date: March 2023
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 7, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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)

Locations

Country	Name	City	State
Norway	Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust	Levanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Norwegian University of Science and Technology, VitalThings

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/hypopnea index	Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep	72 hours
Secondary	Sleep score	Objective (AI-based) score of sleep quality from raw data from sleep monitor	12 weeks