A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Evaluation of safety (adverse events, dental examinations, safety examinations)
研究概览
简要总结
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
详细描述
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea (OSA). Study participants will receive a custom ProSomnus EVO Sleep and Snore device and then be tested using a Type II home sleep apnea test (HSAT) to determine if they have achieved apnea-hypopnea index (AHI) < 15 h-1 with the device in place. Home sleep apnea testing will be conducted at predetermined timepoints rather than based on subjective measures such as symptom alleviation. After completing a set device advancement and testing protocol, study participants will complete a final HSAT six months after therapy initiation. This value will be used to determine the therapeutic success rate of the appliance. Safety evaluations will be conducted at each study visit that takes place after therapy initiation. These evaluations, along with dental examinations and adverse event reports, will be used to determine if the safety endpoint is met. Participants will continue to be followed for an additional six months after collection of data for the primary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, of any race, aged 18-80 years (inclusive)
- •Diagnosed with uncomplicated severe OSA (i.e., AHI > 30 h-1); where uncomplicated is defined by the absence of:
- •Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
- •Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
- •Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
- •Body mass index (BMI) < 40 kg/m2
- •Neck circumference < 50 cm
- •Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 87%
- •Mandibular range of motion > 5 mm in protrusive direction
- •Adequate dentition, as determined by the site dentist
排除标准
- •Inability to breathe through the nose comfortably
- •Presence of > 25% CSA
- •Presence of positional obstructive sleep apnea per Cartwright's definition32
- •History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension. History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted
- •Presence of hypoglossal nerve stimulation device
- •Use of CPAP or OAT within the two weeks prior to the screening HSAT
- •History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
- •Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
- •Loose teeth or advanced periodontal disease
- •History of temporomandibular joint disorder
- •Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
- •Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
- •Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
- •Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
- •History of cerebrovascular incident within the last 12 months
- •Use of pacemaker or other life supporting device
- •Anticipated change in body weight > 5% during the study period
- •Participation in other studies that could interfere with the study protocol
- •Pregnancy or lactation
- •In the opinion of the investigator, unsuitable for inclusion in the study
结局指标
主要结局
Evaluation of safety (adverse events, dental examinations, safety examinations)
时间窗: 6 months
The primary safety endpoint is to demonstrate an acceptable safety profile of the EVO Sleep and Snore Device, determined through assessment of all reported adverse events, dental examinations, and safety evaluations. There will be no formal statistical analysis.
Efficacy (apnea-hypopnea index)
时间窗: 6 months
The AHI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve an AHI \< 15 h-1 with the EVO Sleep and Snore Device 6 months after initiation of the therapy.
Efficacy (oxygen desaturation index)
时间窗: 6 months
The ODI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve decrease in ODI from baseline of 25% or more with the EVO Sleep and Snore Device 6 months after initiation of the therapy.
次要结局
- Epworth Sleepiness Scale(6 months)