Non-comparative Prospective Study Evaluating the Long-term Efficacy, Tolerance and Compliance of the Panthera D-SAD Mandibular Advancement Orthosis in the Management of Obstructive Sleep Apnea Hypopnea Syndrome (PANTHERA Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years
研究概览
简要总结
Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients. The Panthera D-SAD® is a computer aided design (CAD)/computer aided manufacturing (CAM), patient-matched, 3D printed, biocompatible nylon OAT. This five-year, observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD® orthosis on reducing the apnea hypopnea index (AHI) and obstructive sleep apnea-hypopnea syndrome (OSAHS) symptoms. Adherence, tolerance, and side effects will be evaluated.
An estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of OAT, and struggles or refuses continuous positive airway (CPAP) treatment. The professional collaborative nature of the study reflects real-world clinical practice.
Participants will be followed over the course of five years at the following time points. Visits include the following: Specialist in sleep disorders: (1) Inclusion, (2) 3 months, (3) 2 years, (4) 5 years. Specialist in manducatory apparatus (dentist): (1) Inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years The efficacy of the Panthera D-SAD® MAO will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial AHI, when monitored by nocturnal breathing polygraphy (NP) or polysomnography (PSG). Secondary endpoints will also be obtained at the aforementioned time points for reporting. The results of this study will fulfill regulatory requirements for reimbursement in France.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18
- •Moderate OSAHS or severe OSAHS and refuse or intolerance to treatment with continuous positive pressure
- •Patient who has never worn MAO
- •Accepting and able to complete questionnaires in French on the impact of their disease and their quality of life
- •Informed and having signed a written consent
- •Affiliated to a social security system
排除标准
- •One or more contraindications to wearing a mandibular advancement orthosis
- •Central sleep apnea
- •Severe OSAHS associated with another sleep pathology
- •Serious respiratory disorders other than OSAS
- •Severe psychiatric or neurological disorders
- •Progressive cancer and/or chronic joint, inflammatory or immunosuppressive disease
- •Known allergy to one of the components of the medical device
- •Simultaneous participation in another intervention research
- •Vulnerable subjects
结局指标
主要结局
Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years
时间窗: At 5 years after treatment start
Proportion of patients with a reduction in AHI of 50% or more compared to inclusion, measured by polygraphy or somnopolygraphy
次要结局
- Oxygen Desaturation Index (ODI) evolution(3 months, 2 years, 5 years)
- Dental tolerance(Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years)
- Description of snoring(Inclusion, 3 months, 2 years, 5 years)
- Duration with SpO2<90%(Inclusion, 3 months, 2 years, 5 years)
- Titration description(during titration)
- Description of severity groups(Inclusion, 3 months, 2 years, 5 years)
- Minimal oxygen saturation (SpO2)(Inclusion, 3 months, 2 years, 5 years)
- Observance(Inclusion, 3 months, 2 years, 5 year)
- AHI evolution according to severity(Inclusion, 3 months, 2 years, 5 years)
- Change in AHI(3 months, 2 years, 5 years)
- Quality of life assessed by Nottingham Health Profile (NHP) questionnaire(3 months, 2 years, 5 years)
- Satisfaction assessed by a Likert scale(3 months, 2 years, 5 years)
- Description of tiredness(Inclusion, 3 months, 2 years, 5 years)
- Description of sleepiness(Inclusion, 3 months, 2 years, 5 years)