NL-OMON55961招募中不适用
A post-market clinical follow up of the Genio® System for the treatment of Obstructive Sleep Apnea in adults - EliSA
yxoah NV0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •A patient must meet all of the following inclusion criteria to be eligible for
- •inclusion in this study:
- •1. Age above 18 years.
- •2. Body Mass Index (BMI) < 35 kg/m2.
- •3. Cricomental space positive (>= 0 cm). The cricomental space is the distance
- •between the neck and the bisection of a line from the chin to the cricoid
- •membrane when the head is in a neutral position.
- •4. AHI between 15 to 65 events/hour documented by the closest PSG performed at
- •the time of patient ICF signature and within maximum 12 months of screening (as
- •long as the patient stays within ±4kg of their initial weight and has no
- •additional significant comorbidities) and fulfilling the required technical
- •criteria or during the screening phase.
- •5. Non-Positional OSA as per investigator*s assessment or the patient has
- •either not tolerated, has failed or refused positional therapy.
- •6. Combined central and mixed AHI < 25% of the total AHI.
- •7. Has either not tolerated, has failed or refused Positive Airway Pressure
- •(PAP) or Mandibular Advancement Device (MAD) treatments.
- •8. Written informed consent obtained from the patient prior to performing any
- •study specific procedure.
- •9. Willing and capable to comply with all study requirements, including
- •specific lifestyle considerations, performing all follow-up visits and sleep
- •studies, evaluation procedures and questionnaires for the whole duration of the
排除标准
- •Patients meeting any of the following criteria will be excluded from
- •participation in this study:
- •1. Inadequately treated sleep disorders other than OSA that would confound
- •functional sleep assessment:
- •a. Severe chronic insomnia,
- •b. Insufficient sleep syndrome,
- •c. Narcolepsy,
- •d. Restless legs syndrome,
- •e. REM behavior disorder,
- •f. Others deemed sufficient disorders that would confound functional sleep
- •assessment in the judgment of the Investigator.
- •2. Taking medications that in the opinion of the Investigator may alter
- •consciousness, the pattern of respiration, or sleep architecture.
- •3. Major anatomical or functional abnormalities that would impair the ability
- •of the Genio® system to treat OSA:
- •a. Craniofacial abnormalities narrowing the airway or the implantation site,
- •b. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
- •c. Relevant fixed upper airway obstructions (tumor, polyps, nasal obstruction),
- •d. Complete concentric collapse of the soft palate observed during Drug-Induced
- •Sleep Endoscopy (DISE) performed within maximum 24 months of screening and
- •fulfilling the required technical criteria or during the screening phase.
- •e. Congenital malformations in the airway,
- •f. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral
- •unintended tongue deviation during protrusion),
- •g. Others deemed sufficient to impair the ability of the Genio® system to treat
- •OSA in the judgment of the Investigator.
- •4. Inadequately treated psychiatric disease (e.g., psychotic illness,
- •uncontrolled major depression or acute anxiety attacks) that prevents patient
- •compliance with the requirements of the investigational study testing.
- •5. Severe history of drug or alcohol abuse within the previous 3 years.
- •6. Life expectancy < 12 months.
- •7. Any medical illness or condition that contraindicates a surgical procedure
- •under general anesthesia in the judgment of the investigator, or that would
- •prevent the implantation of the Implantable Stimulator or the placement of
- •Activation Chip/Disposable Patch.
- •8. Prior surgery or treatments that could compromise the effectiveness of the
- •Genio® system:
- •a. Airway cancer surgery or radiation,
- •b. Mandible or maxilla surgery in the previous 3 years (not counting dental
- •treatments),
- •c. Other upper airway surgery to remove obstructions related to OSA in the
- •previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal
- •airway surgery),
- •d. Prior hypoglossal nerve stimulation device implantation.
- •9. Has an Active Implantable Medical Device (AIMD) even if the device can be
- •temporarily turned off.
- •10. Participation in another clinical study (excluding registries) during the
- •study period (5 years) with an active treatment arm that could confound the
- •results of the EliSA study.
- •11. Plan to become pregnant, currently pregnant, or breastfeeding during the
- 另有 2 项未显示
研究者
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