N/A
Completed N=367
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT01146782 ↗Enrolled (actual)
367
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 — 26 subjects with clinical success
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 |
26 | — |
| SECONDARY Adverse Event Rate |
0; 87; 80; 65; 15; 0 | — |
| SECONDARY Last Treatment Night Response (AHI Reduction) |
-43.2 | — |
| SECONDARY Percent Reduction in Oxygen Desaturation Index (ODI) |
-41.9 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01146782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.