Obstructive Sleep Apnea
Conditions
Brief 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.
Interventions
Console and mouthpiece sleep apnea system
Sponsors
ApniCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is between the ages of 18 and 80. 2. Diagnosis of OSA, based on ODI 10-60 (as assessed per home screening night). 3. 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. 4. BMI \< 40. 5. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). 6. Subject has proper mouthpiece fit, as assessed by home screening night (See section 8.3).
Exclusion criteria
1. OSA treatment within two weeks prior to Medical/Dental screening visit. 2. 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. 3. 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. 4. Prior use of the Attune Sleep Apnea System. 5. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc. 6. Current use or use within the previous 2 weeks of medications or other agents that may affect sleep or PSG, including: 1. 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. 2. Consumption of \> 500mg caffeine per day (e.g. \> 8 cola-type beverages, \> 5 cups of coffee). 3. 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. 4. Smokers who smoke during the night (interference with PSG). 7. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea. 8. 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. 9. 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. 10. Female subjects who are pregnant or intend to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Rate | 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. |
| Last Treatment Night Response (AHI Reduction) | 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. |
| Percent Reduction in Oxygen Desaturation Index (ODI) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects for the study were recruited from the Investigator's sleep clinic or through advertising. Advertisements were approved by the applicable Institutional Review Board (IRB) prior to use.
Pre-assignment details
Initial screening phase consisted of initial medical/dental and eligibility screening. Subjects then underwent an Oxygen Desaturation Index (ODI) screening (confirming ODI of 10-60) and one night of home use with the study device to screen for proper fit.
Participants by arm
| Arm | Count |
|---|---|
| Safety Cohort Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146) | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Primary Endpoint Cohort | Physician Decision | 1 |
| Primary Endpoint Cohort | Withdrawal by Subject | 5 |
| Safety Cohort | Control AHI <5 | 4 |
| Safety Cohort | Screen Failure | 61 |
| Safety Cohort | TST <4 hrs | 14 |
| Safety Cohort | Withdrawal by Subject | 4 |
| Screening Cohort | Lost to Follow-up | 4 |
| Screening Cohort | Physician Decision | 1 |
| Screening Cohort | Screen Failure | 187 |
| Screening Cohort | Withdrawal by Subject | 29 |
Baseline characteristics
| Characteristic | Safety Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 146 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 80 / 146 |
| serious Total, serious adverse events | 0 / 146 |
Outcome results
Primary
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.
Time frame: first treatment night
Population: All subjects in the primary endpoint cohort were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Endpoint Cohort | Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 | 26 subjects with clinical success |
Secondary
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.
Time frame: 4 weeks
Population: The Safety Cohort consisted of all subjects who participated in at-home use of the device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint Cohort | Adverse Event Rate | Unanticipated Adverse Events | 0 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | All adverse events | 87 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | Device related adverse events | 80 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | Device related AEs categorized as mild | 65 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | Device related AEs categorized as moderate | 15 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | Device related AEs categorized as severe | 0 subjects |
| Primary Endpoint Cohort | Adverse Event Rate | Serious adverse events | 0 subjects |
Secondary
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.
Time frame: At completion of 28 day home use.
Population: All subjects in primary endpoint cohort with final evaluable treatment PSG.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Endpoint Cohort | Last Treatment Night Response (AHI Reduction) | -43.2 AHI reduction (% change) |
Secondary
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.
Time frame: First treatment night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Endpoint Cohort | Percent Reduction in Oxygen Desaturation Index (ODI) | -41.9 ODI reduction (% change) |