- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01146782
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (ATLAST)
28 maj 2014 uppdaterad av: ApniCure, Inc.
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
367
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
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Phoenix, Arizona, Förenta staterna, 85037
- REM Medical
-
-
California
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Burlingame, California, Förenta staterna, 94010
- Peninsula Sleep Center
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Menlo Park, California, Förenta staterna, 94025
- SRI
-
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
- Sleep Disorders Center of Georgia (SDCG)
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29201
- SleepMed
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Texas
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Dallas, Texas, Förenta staterna, 75231
- Sleep Medicine Associates of Texas (SMAT)
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 78 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment
Treatment with the Attune Sleep Apnea System
|
Console and mouthpiece sleep apnea system
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20
Tidsram: 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.
|
first treatment night
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Adverse Event Rate
Tidsram: 4 weeks
|
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.
|
4 weeks
|
Last Treatment Night Response (AHI Reduction)
Tidsram: At completion of 28 day home use.
|
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.
|
At completion of 28 day home use.
|
Percent Reduction in Oxygen Desaturation Index (ODI)
Tidsram: First treatment night
|
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.
|
First treatment night
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ian Colrain, PhD, Stanford Reasearch Institute (SRI)
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2010
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
15 juni 2010
Först inskickad som uppfyllde QC-kriterierna
16 juni 2010
Första postat (Uppskatta)
22 juni 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10753 (Registeridentifierare: DAIDS ES)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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