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

NCT05049135 | Completed

• 2 other identifiers: 200405CIV-NO-21-08-037486
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

sleep monitor

Outcome Measures

Primary Outcomes (1)

• Apnea/hypopnea index

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

  72 hours

Secondary Outcomes (1)

• Sleep score

  12 weeks

Study Arms (2)

Sleep apnea group

Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy

Device: Somnofy® sleep monitor

Control group

partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy

Device: Somnofy® sleep monitor

Interventions

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)

Also known as: Respiratory polygraphy (NOXT3, ResMed AS)

Control group; Sleep apnea group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
• able to sign an informed consent

You may not qualify if:

• Pregnancy
• Serious disease which could affect ability to complete the study
• Complicated sleep disorders

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator
• VitalThings: collaborator

Study Sites (1)

Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust

Levanger, Norway

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 7, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

NO (1)