Obstructive Sleep Apnea (OSA)Phase 2/3NCT01476917
The ATLAST Long-Term Study
A Phase 2/3 study testing Attune Sleep Apnea System in people with Obstructive Sleep Apnea (OSA), run by ApniCure, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Attune Sleep Apnea System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 2/3
- 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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
Penninsula Sleep Center (PSC)
Burlingame, California, 94010
SleepMed
Columbia, South Carolina, 29201
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, 75231
SRI International
Menlo Park, California, 94025
REM Medical
Phoenix, Arizona, 85037
About this study
Official 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)
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Attune Sleep Apnea System
- 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.
Attune Sleep Apnea SystemDevice
Observation of Attune Sleep Apnea System for use during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects that completed the ATLAST Study Receives: Device: Attune Sleep Apnea System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of hours per night of device use over a 3-month period
Nightly use will be monitored over a 3-month take-home period.
Measured: Each night's use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApniCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Colrain, PhD, Principal investigator, Stanford Research Institute (SRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476917
- Sponsor's protocol ID
- 11449
- Status last verified
- Nov 2012
- First submitted
- 16 Nov 2011
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01476917
- Acronym / sponsor ID
- 11449
- Conditions
- Obstructive Sleep Apnea (OSA)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- ApniCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Nov 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Attune Sleep Apnea SystemSubjects that completed the ATLAST Study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Attune Sleep Apnea SystemObservation of Attune Sleep Apnea System for use during sleep. | Device | Treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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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.
Ian Colrain, PhD principal investigator
Stanford Research Institute (SRI)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Attune Sleep Apnea System in people with Obstructive Sleep Apnea (OSA), run by ApniCure, Inc. at 6 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 4 inclusion and 4 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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean number of hours per night of device use over a 3-month period (time frame: Each night's use). 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 7 Nov 2012.