NCT07720219尚未招募不适用
Obstructive Sleep Apnea Severity Reduction by AdIpose CryolysiS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cryosa, Inc.
- 入组人数
- 130
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.
详细描述
This is a multi-center, prospective, non-randomized, single-arm clinical trial in adult patients with moderate to severe Obstructive Sleep Apnea (OSA)
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant age is 22 years and older
- •Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD)
- •Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA/MA ≤ 25%)
- •Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies
- •Participant is willing and capable of providing informed consent
排除标准
- •Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing
- •Any reason for which, in the judgment of the investigator, the participant is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study (e.g. uncontrolled Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease)
- •Participant has a BMI > 40 kg/m2 at enrollment
- •Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up.
- •Concomitant Medication Exclusions
- •Participant is actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender, or >65 years of age
- •Participant is actively undergoing immunotherapy (Allergy shots), and unwilling to wash out of allergy shots at least 2 weeks prior to study procedure
- •Participant is taking any of the following medications that, in the opinion of the investigator, could affect study endpoints: AD109, benzodiazepines, Z-drugs (zolpidem and eszopiclone), opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)
- •Significant Airway Risk Factors
- •Participants with severe uncontrolled asthma
- •Participants with a history of angioedema
- •Participants with hereditary angioedema (confirmed with a Complement Component C4 blood test <13mg/dL)
- •Participant has uncontrolled autoimmune disorders including active thyroid disease, lupus, multiple myeloma, and chronic lymphocytic leukemia that could lead to acquired angioedema
- •Participant has a history or presence of cold urticaria at the time of screening
- •Participant has a history of cryoglobulinemia or Paradoxical Adipose Hyperplasia (PAH)
- •Participant has a history of allergy to glycerin History of Oral/Airway Comorbidities/Interventions
- •Participant has a prior airway interventions that alter or excise the tissue of the soft palate or the tongue base
- •Participant has any airway intervention within 12 weeks of scheduled procedure performed to alter or excise the soft tissue of the airway or larynx
- •Participant has an active, implanted, nerve stimulator for the treatment of OSA
- •Participant has oral cancer or non-healing oral wounds
- •Participant has a history of radiation therapy to neck or upper respiratory tract
- •Participant has other severe sleep disorders that, in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia/insomnia secondary to chronic pain, PTSD
- •Major Anatomical Exclusions
- •Participant has severe maxillary mandibular insufficiency or obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) that, in the opinion of the investigator, is thought to be the primary cause of OSA
- •Participant has obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)
- •Participant has lingual tonsils size 4+
- •Participant has Friedman tongue position IV
- •Participant has a mandibular intermolar width < 32mm
- •Participant has trismus as defined by a maximal inter-incisal opening of < 35mm
- •Significant Comorbidities that Contraindicate Surgery or General Anesthesia
- •Participant has resistant hypertension, defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses
- •Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
- •Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
- •Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9 at time of screening.
- •Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 months) myocardial infarction or severe cardiac arrhythmias
- •Participants with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
- •Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
- •Participant has contraindication to general anesthesia or, in the opinion of the Investigator, would not be able to tolerate the procedure, including intubation during the procedure
- •Lifestyle considerations
- •Participant is a current smoker or nicotine vaper (>1 pack/day or equivalent)
- •Participant conducts work or regular activities requiring vigilance (e.g., commercial driver, heavy machine operator, shift worker, etc.) that does not accommodate untreated OSA.
- •Participant has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG
- •Participant exhibits ongoing misuse of alcohol or recreational drugs that would impact either the results of or the participation in a sleep study
结局指标
主要结局
Primary Safety Endpoint
时间窗: 6 Months, 12 Months
The safety of the Cryosa System will be assessed via the description of all reported adverse events. Adverse events will be summarized by seriousness, severity and relatedness to the device and/or procedure
Primary Co-Efficacy AHI Responder Endpoint
时间窗: 6 Months
Reduction in AHI of ≥ 50% or 15 points improvement at 6 months compared to baseline.
Primary Co-Efficacy ODI Responder Endpoint
时间窗: 6 Months
Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline.
次要结局
未报告次要终点
研究者
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