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Completed

NCT Number: NCT02034175

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Central Sleep Apnea Cheyne-Stokes Respiration Dyssomnias Mixed Sleep Apnea Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preferred Research Partners, Inc, Little Rock, Arkansas, United States

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About this study

This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.

The study includes the following steps:

Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.

Initial visit, includes:

  • Consent discussion and signature
  • History, vital signs, and physical exam

Night study

a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.

Additional visits If side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign the informed consent
  • Able to comply with visits and follow ups included in this protocol
  • Ages 20-85 years

Exclusion criteria

  • An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
  • Skin rash on the nose or on the maxillary area.
  • A history of skin allergy to medical tape, and hypoallergenic tapes.
  • A history of skin cancer on the nose or on the maxillary area.
  • A history of the base of skull fractures, facial fractures

Treatment and study plan

SomnaPatch

Device

SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.

Polysomnography

Device

Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.

Primary outcomes

  1. Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)

    Time frame: 1 night

    AHI is the number of apneas and hypopneas that occur over an hour during the course of the night. The SomnaPatch and PSG were wore simultaneously over the night. The results from the SomnaPatch and PSG were compared per individual for agreement

Sponsors and collaborators

Lead sponsor

Somnarus Inc

Industry

Registry information

Official study title

Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2014
Registry last updated
Oct 3, 2019

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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