Obstructive Sleep ApneaNCT02034175
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
A study testing SomnaPatch and Polysomnography in people with Obstructive Sleep Apnea and Central Sleep Apnea, run by Somnarus Inc at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea
- What is being tested?
- SomnaPatch and Polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign the informed consent
- Able to comply with visits and follow ups included in this protocol
- Ages 20-85 years
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Peninsula Sleep Center
Burlingame, California, 94010
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211
The Good Sheperd Sleep Center, LLC
Tampa, Florida, 33635
About this study
Official title: Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
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).
Read the 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:
- Consent discussion and signature
- History, vital signs, and physical exam
Night study
- 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.
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- Being tested
- SomnaPatch, Polysomnography
- Keywords
- apnea, hypopnea, polysomnography, respiratory, cheyne
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central, Sleep Apnea Syndromes, Cheyne-Stokes Respiration, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomnaPatchDevice
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
PolysomnographyDevice
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
| Study group | Role | What they receive |
|---|---|---|
| SomnaPatch | Experimental | SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. Receives: Device: SomnaPatch |
| Polysomnography | Active comparator | Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. Receives: Device: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start1 Feb 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnarus Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merhan Farid-Moayer, MD, Principal investigator, Peninsula Sleep Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034175
- Sponsor's protocol ID
- SomnaPatch-001-D
- Status last verified
- Sep 2019
- First submitted
- 9 Jan 2014
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT02034175
- Acronym / sponsor ID
- SomnaPatch-001-D
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- Keywords
- apnea, hypopnea, polysomnography, respiratory, cheyne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Somnarus IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 18 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Consent discussion and signature
- History, vital signs, and physical exam
Night study
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SomnaPatch | Experimental | Device: SomnaPatchSomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. |
| Polysomnography | Active comparator | Device: PolysomnographyPolysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and sign the informed consent
- Able to comply with visits and follow ups included in this protocol
- Ages 20-85 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomnaPatchSomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. | Device | SomnaPatch |
| PolysomnographyPolysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. | Device | Polysomnography |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merhan Farid-Moayer, MD principal investigator
Peninsula Sleep Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SomnaPatch and Polysomnography in people with Obstructive Sleep Apnea and Central Sleep Apnea, run by Somnarus Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.