obstructive sleep apneu syndrome (OSAS)
Conditions
Interventions
The Inspire II system is intended for the treatment of obstructive sleep
apnea. The system is comprised of the following components with additional
details about each component described in the prot
Sponsors
Inspire Medical Systems Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Suffer from moederate to severe OSA (AHI * 20) 2. Have failed or have not tolerated CPAP treatment 3. Age 22 or above 4. Willing and capable of providing informed consent and to return for all follow*up visits and sleep studies, including the evaluation procedures and filling out the questionnaires.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) of > 32 2. Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat (Note that some prior surgeries to remove obstructions related to obstructive sleep apnea are allowed; such as uvulopalatopharyngoplasty, tonsillectomy, or adenoidectomy) 3. Hypoglossal nerve palsy (obvious limited tongue movement, such as inability to protrude tongue, or unintended lateral deviation of the tongue when protruding). 4. Previous surgery within 12 weeks of scheduled implant performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils). 5. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) 6. Intrinsic neuromuscular disease, or other neurologic deficits (for examplee.g., multiple sclerosis, muscular dystrophy, Parkinson*s disease, amyotrophic lateral sclerosis, epilepsy, transient ischemic attack, or cerebrovascular accident) 7. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis), which may be) such as a normal or high FEV1/FVC with an FEV1 less than 50% of predicted, or severe chronic obstructive pulmonary disease (COPD) indicated by FEV1 (forced expiratory volume) < 50% predicted or FEV1/ FVC (forced vital capacity) ratio < 50% 8. Active, severe pulmonary vascular disease (0.7 as defined by the Global Initiative for example pulmonary arterial hypertension or pulmonary embolism)Chronic Obstructive Lung Disease (GOLD); Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease updated 2009 9. Moderate to severe pulmonary arterial hypertension as defined as Class III or higher as defined by the World Health Organization functional class, WHO FC) or documented by direct measurements of mean pulmonary arterial pressure by heart catheterization (PAPmean * 30 mmHg) or estimates of systolic pulmonary arterial pressure by echocardiogram (PAsys * 40 mmHg) [Barst RJ, McGoon M, Torbicki A, et al. Diagnosis and differential assessment of pulmonary arterial hypertension. J Am Coll Cardiol 2004;43:40S-47S] 10. Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg 11. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 6 month) myocardial infarction or severe cardiac arrhythmias 12. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months 13. Persistent uncontrolled hypertension (defined as systolic pressure *160 mm Hg or a diastolic pressure of * 100 mm Hg) despite medications 14. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents patient compliance with the requirements of the investigational study testing 15. Other sleep disorders that confound functional assessments of sleepiness such as narcolepsy with cataplexy, insomnia, or sleep movement disorders such as restless leg syndrome or periodic limb movement producing sleep disturbances unrelated to obstructive sleep apnea 16. Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture. Medications not given explicitly to impact nighttime sleep may be al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1st Efficacy Endpoint: The primary endpoint is the responder rate at the 12-Month follow-up visit. A responder to the Inspire therapy is defined as a subject with at least a 50% reduction of apnea and hypopnea events per hour (AHI) compared to the 1-Month visit, and AHI less than 20 events per hour. Co-primary Endpoint is the percentage of study subjects with a 25% reduction in ODI at the 12-Month visit compared to the 1-Month visit. 1st Safety Endpoint: Safety of the Inspire system will be assessed via two primary safety objectives that will assess the acute safety of the device system and implant procedure and the long-term safety of the systemquantitative assessment of all adverse events identified in the first 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2o Endpoints: Evaluate the following · Randomized therapy withdrawal study · Modified intent-to-treat analysis of Inspire effect on AHI · Functional Outcomes of Sleep Questionnaire (FOSQ) · Epworth Sleepiness Scale (ESS) · Percentage of time SaO2 below 90% In addition to the primary and secondary endpoint analyses, other supplementary data will be collected as part of the study protocol to ensure patient safety and for further examination of the effect of the therapy. | — |
Countries
Netherlands
Outcome results
None listed