Trial record 13 of 981 for:
"Sleep Apnea Syndromes"
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Verified January 2014 by Somnarus Inc
Information provided by (Responsible Party):
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
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).
Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
||Observational Model: Case-Crossover
Time Perspective: Prospective
|Target Follow-Up Duration:
||Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
Primary Outcome Measures:
- Apnea-Hypopnea Index [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||20 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient who have been diagnosed with sleep disordered breathing (apnea or Cheyne-Stokes respiration)
- Able to understand and sign the informed consent
- Able to comply with visits and follow ups included in this protocol
- Ages 20-85 years
- 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
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
|Peninsula Sleep Center
|Burlingame, California, United States |
|Contact: Juliann Nealon, MD 650-636-9396 |
|Principal Investigator: Mehran Farid-Moayer, MD |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 9, 2014
||January 9, 2014
||United States: Food and Drug Administration
Keywords provided by Somnarus Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 15, 2014
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Nervous System Diseases