2025-524819-37-00招募中4 期
TheRapeutic StrAtegies for Obstructive SleeP Apnea in Older Adults with OverweigHt or Obesity: A RandomizEd Clinical TriaL (RAPHAEL study)
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre3 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2026年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 345
- 试验地点
- 3
- 主要终点
- The change in Apnea–Hypopnea Index (AHI) at 6 months
研究概览
简要总结
The primary outcome will be the change in OSA severity from baseline to the 6-month follow-up.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years.
- •Diagnosis of moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥15 events/h), determined by a home-based sleep apnea test, with clinical indication for active treatment according to the International Consensus Document on OSA (PMID: 33875282)
- •Overweight or obesity (body mass index [BMI] ≥27 kg/m²), consistent with recommendations for semaglutide use in individuals with BMI ≥30 kg/m² or ≥27 kg/m² with weight-related comorbidities.
排除标准
- •Presence or suspicion of another sleep disorder.
- •>50% central apneas or Cheyne–Stokes respiration
- •Excessive daytime sleepiness (Epworth Sleepiness Scale ≥18)
- •Participation in a weight-loss program
- •Inability to adhere to interventions or assessments
- •Type 1 or type 2 diabetes.
- •Severe chronic illness (e.g., neoplasia, renal failure, severe COPD, chronic depression).
- •Social or geographic limitations affecting adherence.
- •Any clinical indication for which continuous positive airway pressure (CPAP) is deemed mandatory by the referring physician.
结局指标
主要结局
The change in Apnea–Hypopnea Index (AHI) at 6 months
The change in Apnea–Hypopnea Index (AHI) at 6 months
次要结局
- Cost-effectiveness.
- Blood pressure.
- OSA pathophysiology (hypoxic burden, delta heart rate, loop gain).
- Symptoms (daytime sleepiness).
- Functional and psychological domains (quality of life, sleep quality, circadian rest-activity rhythm, cognitive function, mental health).
- Body weight.
- Molecular mechanisms (biomarkers of inflammation, oxidative stress, obesity, and cardiovascular risk).
研究者
Diego Arango Del Corro
Scientific
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
研究点 (3)
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