Trial record 13 of 960 for:    "Sleep Apnea Syndromes"

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Somnarus Inc
Sponsor:
Information provided by (Responsible Party):
Somnarus Inc
ClinicalTrials.gov Identifier:
NCT02034175
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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
Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
Cheyne-Stokes Respiration

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Somnarus Inc:

Primary Outcome Measures:
  • Apnea-Hypopnea Index [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034175

Contacts
Contact: Maria Merchant, PhD 408-761-0884 somnarus@gmail.com

Locations
United States, California
Peninsula Sleep Center Recruiting
Burlingame, California, United States
Contact: Juliann Nealon, MD    650-636-9396      
Principal Investigator: Mehran Farid-Moayer, MD         
Sponsors and Collaborators
Somnarus Inc
  More Information

No publications provided

Responsible Party: Somnarus Inc
ClinicalTrials.gov Identifier: NCT02034175     History of Changes
Other Study ID Numbers: SomnaPatch-001
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Somnarus Inc:
apnea
hypopnea
polysomnography
respiratory
cheyne

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

ClinicalTrials.gov processed this record on July 26, 2014