NCT02034175

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 18, 2019

Completed
Last Updated

October 3, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

January 9, 2014

Results QC Date

July 25, 2018

Last Update Submit

September 19, 2019

Conditions

Obstructive Sleep ApneaCentral Sleep ApneaMixed Sleep ApneaCheyne-Stokes Respiration

Keywords

apneahypopneapolysomnographyrespiratorycheyne

Outcome Measures

Primary Outcomes (1)

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

    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

    1 night

Study Arms (2)

SomnaPatch

EXPERIMENTAL

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

Device: SomnaPatch

Polysomnography

ACTIVE COMPARATOR

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

Device: Polysomnography

Interventions

SomnaPatchDEVICE

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

SomnaPatch
PolysomnographyDEVICE

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

Polysomnography

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Preferred Research Partners, Inc

Little Rock, Arkansas, 72211, United States

Location

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location

The Good Sheperd Sleep Center, LLC

Tampa, Florida, 33635, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea, CentralSleep Apnea SyndromesCheyne-Stokes RespirationApnea

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Maria Merchant
Organization
Somnarus Inc
somnarus@gmail.com
4087610884

Study Officials

  • Merhan Farid-Moayer, MD

    Peninsula Sleep Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

February 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

October 3, 2019

Results First Posted

January 18, 2019

Record last verified: 2019-09

Locations

US(3)