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Completed

NCT Number: NCT01476917

The ATLAST Long-Term Study

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

REM Medical, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attune Sleep Apnea System

Device

Observation of Attune Sleep Apnea System for use during sleep.

Primary outcomes

  1. Mean number of hours per night of device use over a 3-month period

    Time frame: Each night's use

    Nightly use will be monitored over a 3-month take-home period.

Sponsors and collaborators

Lead sponsor

ApniCure, Inc.

Industry

Registry information

Official study title

The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2011
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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