Apnea, Apnea+Hypopnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Hypopnea, Sleep, Obstructive Sleep Apnea, OSA
Conditions
Keywords
OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP
Brief summary
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
Detailed description
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit. The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13) Safety and efficacy will be evaluated at Month 7, and again at Month 13.
Interventions
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Sponsors
LivaNova
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
PSG results are masked from the Investigator and Outcomes Assessor.
Intervention model description
All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13. Additionally, the long-term phase allows for continued collection of data for safety, efficacy, and quality of life for up to four years from the time the subject completes the final M13 visit.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Abbreviated: Additional criteria may apply: Inclusion Criteria: * Diagnosis of moderate to severe OSA * Declines to use or does not tolerate PAP therapy
Exclusion criteria
* Respiratory, cardiac, renal disease or other co-morbid conditions * BMI \> 35 kg/m2 * Specific PSG criteria outlined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of response to therapy when compared to no therapy for 6 months | Month 1 through Month 7 | The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7. |
| Rate of all serious adverse device/procedure related events from time of implant through month 7 | Month 1 through Month 7 | The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC). |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in Oxygen Desaturation Index (Efficacy) | Baseline through Month 7 |
| Change in Functional Outcomes of Sleep Questionnaire (Efficacy | Baseline through Month 7 |
| Change in Epworth Sleepiness Scale (Efficacy) | Baseline through Month 7 |
| Change in EQ-5D (Efficacy) | Baseline through Month 7 |
| Change in PROMIS SDI/SRI (Efficacy) | Baseline through Month 7 |
| Change in SF-36 (Efficacy) | Baseline through Month 7 |
| Change in CGI-S/CGI-I (Efficacy) | Baseline through Month 7 |
| Descriptive analysis of all reported Adverse Events (Safety) | Consent through Month 7 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAtul Malhotra, MD
UCSD Pulmonary and Critical Care Medicine
Outcome results
None listed