Obstructive Sleep ApneaNCT01634074
Reiterative Development and Evaluation Study of OSA Therapy System
An observational study of Obstructive Sleep Apnea, run by ApniCure, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected OSA
Who may be able to join
- Subject is between the ages of 18 and 80.
- Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
- Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
Who cannot join
- Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
- History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- Currently working nights, or rotating night shifts.
- Current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
- Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Sleep Disorders Center of Georgia (SDCG)
Atlanta, Georgia, 30342
Alan Lankford, PhD, 404-257-0080, alankford@sleepsciences.com
Alan Lankford, PhD
- Recruiting
Penninsula Sleep Center (PSC)
Burlingame, California, 94010
Mehran Farid-Moayer, MD, 650-636-9396, mehran@peninsulasleep.com
Mehran Farid-Moayer, MD
- Recruiting
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Jaime Stiles, 301-654-5665
Helene A Emsellem, MD
- Recruiting
SleepMed
Columbia, South Carolina, 29201
Richard Bogan, MD, 803-251-3093, rbogan@sleepmed.md
Richard Bogan, MD
- Recruiting
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, 75231
Philip Becker, MD, 214-389-1740 ext. 305, research@sleepmed.com
Philip Becker, MD
- Recruiting
Kentucky Research Group
Louisville, Kentucky, 40218
Pamela A McCullough, PhD, APRN, CCRC, 502-479-1217
David H Winslow, MD
- Recruiting
ApniCure, Inc.
Redwood City, California, 94063
Andrea L Brown, M.S., 650-361-9300 ext. 122, abrown@apnicure.com
Lawrence Siegel, MD
About this study
Official title: A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA patients | Patients with Obstructive Sleep Apnea (OSA), or suspected OSA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ApniCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mehran Farid-Moayer, MD, Principal investigator, Peninsula Sleep lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634074
- Sponsor's protocol ID
- 11847
- Status last verified
- Nov 2013
- First submitted
- 3 Jul 2012
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT01634074
- Acronym / sponsor ID
- 11847
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ApniCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
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 new iterations/generations of the ApniCure sleep therapy device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA patients | – | –Patients with Obstructive Sleep Apnea (OSA), or suspected OSA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected OSA
Key inclusion criteria (3 listed)
- Subject is between the ages of 18 and 80.
- Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
- Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
Key exclusion criteria (7 listed)
- Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
- History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- Currently working nights, or rotating night shifts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Sleep Disorders Center of Georgia (SDCG)
Atlanta, United States
Mehran Farid-Moayer, MD principal investigator
Peninsula Sleep lab
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by ApniCure, Inc. at 7 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 7 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: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 25 Nov 2013.