Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Change in Apnea Hypopnea Index (AHI4%)
研究概览
简要总结
The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
详细描述
BREATHE is a multicenter, prospective, single-arm, post-approval study. Following a baseline visit and implantation of the Genio® System 2.1, subjects will be asked to return for a therapy activation visit at approximately 8 weeks post-implant surgery.
The subject will have follow-up visits at 6 months, 9 months, 12 months and every 6-months thereafter up to 5 years post-implant surgery. Additional visits (for device titration or other reasons) are per standard of care and at the Investigator's discretion. Endpoints will be assessed at 12, 24, 36, 48 and 60 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).
- •Be adults 22 years of age and older.
- •Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.
- •Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.
- •Agree to participate in the study and voluntarily sign and date an informed consent form.
- •Be willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits, evaluation procedures and questionnaires for the whole duration of the trial.
- •Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.
排除标准
- •Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
- •Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
- •Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.
- •Women who are pregnant, planning to become pregnant or breastfeeding.
- •Any condition or procedure that has compromised neurological control of the upper airway.
- •Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
- •Patients below 22 or above 75 years of age.
- •Patients with a Body Mass Index (BMI) above 32 kg/m
- •Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr.
- •Patients with Complete Concentric Collapse (CCC) at the soft palate level.
研究组 & 干预措施
Genio System 2.1
This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System.
干预措施: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1 (Device)
结局指标
主要结局
Change in Apnea Hypopnea Index (AHI4%)
时间窗: 12 months
Percentage of responders at 12 months based on AHI4
Change in Oxyhemoglobin Desaturation Index (ODI4%)
时间窗: 12 months
Percentage of responders at 12 months based on ODI4
Device-related and procedure-related SAEs
时间窗: 12 months
Incidence of device-related and procedure-related SAEs at 12 months post-surgery
Device related SAEs
时间窗: 12 months
Incidence of device-related Serious Adverse Events at 12 months post-surgery
次要结局
- Mean change in AHI4(Baseline to 5 years)
- Mean change in ODI4(Baseline to 5 years)
- % responders AHI4(2 years through 5 years)
- % responders ODI4(2 years through 5 years)
- Subject Satisfaction(1 year through 5 years)
- Improvement in ESS(1 year through 5 years)
- Change in health status(1 year through 5 years)
- Clinician impression of change in Subject's health status(1 year through 5 years)
- Device-related Serious Adverse Events(2 years through 5 years)