The ATLAST Long-Term Study

NCT ID: NCT01476917

Last Updated: 2012-11-07

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-10-31

Brief Summary

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The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.

Detailed Description

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Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Subjects that completed the ATLAST Study

Group Type EXPERIMENTAL

Attune Sleep Apnea System

Intervention Type DEVICE

Observation of Attune Sleep Apnea System for use during sleep.

Interventions

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Attune Sleep Apnea System

Observation of Attune Sleep Apnea System for use during sleep.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject participated in the ATLAST Study, and completed the 28-day take-home period
* Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
* The study physician and investigator believe that study participation is appropriate for the subject.
* Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria

* Female subjects who are pregnant or intend to become pregnant during the study period.
* 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 Attune Sleep Apnea System
* History of any OSA surgical treatment
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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Ian Colrain, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford Research Institute (SRI)

Locations

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REM Medical

Phoenix, Arizona, United States

Site Status

Penninsula Sleep Center (PSC)

Burlingame, California, United States

Site Status

SRI International

Menlo Park, California, United States

Site Status

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

Site Status

SleepMed

Columbia, South Carolina, United States

Site Status

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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11449

Identifier Type: -

Identifier Source: org_study_id