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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
Results First Posted : January 18, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Somnarus Inc

Tracking Information
First Submitted Date  ICMJE January 9, 2014
First Posted Date  ICMJE January 13, 2014
Results First Submitted Date  ICMJE July 25, 2018
Results First Posted Date  ICMJE January 18, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE February 1, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
Apnea-Hypopnea Index [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Official Title  ICMJE Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
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).
Detailed Description

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:

  1. Consent discussion and signature
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual.
Primary Purpose: Screening
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Central Sleep Apnea
  • Mixed Sleep Apnea
  • Cheyne-Stokes Respiration
Intervention  ICMJE
  • Device: SomnaPatch
    SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
  • Device: Polysomnography
    Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Study Arms  ICMJE
  • Experimental: SomnaPatch
    SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
    Intervention: Device: SomnaPatch
  • Active Comparator: Polysomnography
    Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
    Intervention: Device: Polysomnography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2017)
190
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2014)
60
Actual Study Completion Date  ICMJE November 30, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034175
Other Study ID Numbers  ICMJE SomnaPatch-001-D
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Somnarus Inc
Study Sponsor  ICMJE Somnarus Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merhan Farid-Moayer, MD Peninsula Sleep Center
PRS Account Somnarus Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP