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Reiterative Development and Evaluation Study of OSA Therapy System

NCT ID: NCT01634074

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA patients

Patients with Obstructive Sleep Apnea (OSA), or suspected OSA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Subject is between the ages of 18 and 80.
2. 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.
3. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria

1. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
2. 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.
3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
5. Currently working nights, or rotating night shifts.
6. 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.
7. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ApniCure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehran Farid-Moayer, MD

Role: PRINCIPAL_INVESTIGATOR

Peninsula Sleep lab

Locations

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Penninsula Sleep Center (PSC)

Burlingame, California, United States

Site Status RECRUITING

ApniCure, Inc.

Redwood City, California, United States

Site Status RECRUITING

Sleep Disorders Center of Georgia (SDCG)

Atlanta, Georgia, United States

Site Status RECRUITING

Kentucky Research Group

Louisville, Kentucky, United States

Site Status RECRUITING

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, United States

Site Status RECRUITING

SleepMed

Columbia, South Carolina, United States

Site Status RECRUITING

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Mehran Farid-Moayer, MD

Role: primary

Andrea L Brown, M.S.

Role: primary

Alan Lankford, PhD

Role: primary

Pamela A McCullough, PhD, APRN, CCRC

Role: primary

Jaime Stiles

Role: primary

Richard Bogan, MD

Role: primary

Philip Becker, MD

Role: primary

Other Identifiers

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11847

Identifier Type: -

Identifier Source: org_study_id