Obstructive Sleep ApneaATLASTNCT01146782
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
A study testing Attune Sleep Apnea System in people with Obstructive Sleep Apnea, run by ApniCure, Inc. at 6 sites in United States.
Trial summary
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA marketing clearance of the device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- 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
- 367 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 is between the ages of 18 and 80.
- Diagnosis of OSA, based on ODI 10-60 (as assessed per home screening night).
- 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.
- BMI < 40.
- Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
- Subject has proper mouthpiece fit, as assessed by home screening night (See section 8.3).
Who cannot join
- OSA treatment within two weeks prior to Medical/Dental screening visit.
- Poor nasal patency as evidenced by Peak Nasal Inspiratory Flow (PNIF) less than 75 l/min (assessed at baseline medical visit). In addition, any ongoing process or condition that limits nasal breathing or indications thereof, including: obligate mouth-breathing, persistent blockage of one or both nostrils resulting in the inability to sleep with the mouth closed, chronic nasal congestion, chronic allergic rhinitis, and intermittent allergic rhinitis that does not respond to non-sedating/non-stimulating medical therapy.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea 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.
- Prior use of 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.
- Current use or use within the previous 2 weeks of medications or other agents that may affect sleep or PSG, including:
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- Hypnotics, anxiolytics, anticonvulsants, sedating antihistamines, stimulants, sedating antidepressants or other medications likely to affect neurocognitive function and/or alertness. Patients on stable selective serotonin reuptake inhibitor (SSRI) therapy for > 3 months and who are expected to remain on therapy for the Study duration, may continue SSRI treatment.
- Consumption of > 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee).
- Any known illicit drug use or abuse within the past year, or failure to pass drug urine screen test, or alcohol breathalyzer test with result over 0.05% BAL.
- Smokers who smoke during the night (interference with PSG).
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- Currently working nights, rotating night shifts, planned travel across four or more time zones required during Study period, or within two weeks prior to Study enrollment, or sleep schedule not compatible with sleep lab practices.
- Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including NYHA class III or IV heart failure, CAD with angina or MI/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the Study.
- Female subjects who are pregnant or intend to become pregnant during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sleep Disorders Center of Georgia (SDCG)
Atlanta, Georgia, 30342
Peninsula Sleep Center
Burlingame, California, 94010
SleepMed
Columbia, South Carolina, 29201
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, 75231
SRI
Menlo Park, California, 94025
REM Medical
Phoenix, Arizona, 85037
About this study
Official title: The ATLAST Trial - A Multicenter, Prospective Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA marketing clearance of the device.
- Conditions
- Obstructive Sleep Apnea
- 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
Console and mouthpiece sleep apnea system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the Attune Sleep Apnea System Receives: Device: Attune Sleep Apnea System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20
Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.
Measured: first treatment night
Secondary outcomes (3)
Adverse Event Rate
Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.
Measured: 4 weeks
Last Treatment Night Response (AHI Reduction)
Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.
Measured: At completion of 28 day home use.
Percent Reduction in Oxygen Desaturation Index (ODI)
Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.
Measured: First treatment night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 367 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 Reasearch Institute (SRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146782
- Sponsor's protocol ID
- 10753
- Acronym
- ATLAST
- Status last verified
- May 2014
- First submitted
- 15 Jun 2010
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ATLAST Trial - A Multicenter, Prospective Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT01146782
- Acronym / sponsor ID
- ATLAST / 10753
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- ApniCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA marketing clearance of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Attune Sleep Apnea SystemTreatment with the Attune Sleep Apnea System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is between the ages of 18 and 80.
- Diagnosis of OSA, based on ODI 10-60 (as assessed per home screening night).
- 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.
- BMI < 40.
- 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 (14 listed)
- OSA treatment within two weeks prior to Medical/Dental screening visit.
- Poor nasal patency as evidenced by Peak Nasal Inspiratory Flow (PNIF) less than 75 l/min (assessed at baseline medical visit). In addition, any ongoing process or condition that limits nasal breathing or indications thereof, including: obligate mouth-breathing, persistent blockage of one or both nostrils resulting in the inability to sleep with the mouth closed, chronic nasal congestion, chronic allergic rhinitis, and intermittent allergic rhinitis that does not respond to non-sedating/non-stimulating medical therapy.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea 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.
- Prior use of 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.
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 SystemConsole and mouthpiece sleep apnea system | Device | Treatment |
Primary outcome
Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20
Time frame: first treatment night
Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.
3 secondary outcomes
Adverse Event Rate
Time frame: 4 weeks
Last Treatment Night Response (AHI Reduction)
Time frame: At completion of 28 day home use.
Percent Reduction in Oxygen Desaturation Index (ODI)
Time frame: First treatment night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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 Reasearch Institute (SRI)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attune Sleep Apnea System in people with Obstructive Sleep Apnea, 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 6 inclusion and 14 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 30 Jun 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 (time frame: first treatment night). 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 30 Jun 2014.