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Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

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ClinicalTrials.gov Identifier: NCT02034175
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Somnarus Inc

Brief Summary:
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).

Condition or disease
Obstructive Sleep Apnea Central Sleep Apnea Mixed Sleep Apnea Cheyne-Stokes Respiration

Study Type : Observational [Patient Registry]
Actual Enrollment : 190 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
Study Start Date : January 2014
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

group 1

Primary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who have been diagnosed with sleep disordered breathing (apnea or Cheyne-Stokes respiration)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034175

United States, California
Peninsula Sleep Center
Burlingame, California, United States
Sponsors and Collaborators
Somnarus Inc

Responsible Party: Somnarus Inc
ClinicalTrials.gov Identifier: NCT02034175     History of Changes
Other Study ID Numbers: SomnaPatch-001
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

Keywords provided by Somnarus Inc:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Cheyne-Stokes Respiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases