Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Helse Nord-Trøndelag HF
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Apnea/hypopnea index
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Apnea/hypopnea index
Time Frame: 72 hours
Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep
Secondary Outcomes
- Sleep score(12 weeks)