NCT04890431Unknown4 期
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study
Hospital St. Joseph, Marseille, France3 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- FSS (Fatigue Severity Scale) score
研究概览
简要总结
The hypothesis of the OXYSED study is that the delivery of 3 months of oxygen therapy via an oxygen concentrator would reduce fatigue, pain, headaches, kinesiophobia, drug intake, dyspnea, and improve walking performance, quality of sleep and quality of life of patients with Ehlers Danlos syndrome hypermobility type (EDS / HT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged ≥ 18 years;
- •Diagnosed with EDS/HT defined by the New York critieria;
- •With intense fatigue defined by an FSS ≥ 4;
- •Having given free and informed written consent;
- •Speaking french language;
- •Being affiliated with or benefiting from a social security scheme.
排除标准
- •with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smoking emphysema);
- •having an ongoing pregnancy or breastfeeding;
- •who have already received oxygen therapy for the EDS / HT indication in the last 6 months;
- •having a pathology that causes fatigue, which is not compensated or treated; non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies including severe depression, organ failure (cardiac, renal, respiratory, hepatic), endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies;
- •Subject to a measure for the protection of justice.
研究组 & 干预措施
Oxygen
Experimental
干预措施: Oxygen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
FSS (Fatigue Severity Scale) score
时间窗: 10 months
次要结局
- PRISM (Pictorial Representation of Illness and Self Measure) score(7 and 10 months)
- SF-36 quality of life questionnaire (Short Form Heath Survey) score(7 and 10 months)
- TSK (Tampa Scale Kinesiophobia) score(7 and 10 months)
- walk test results(7 and 10 months)
- HIT-6 (Headache Impact Test) score(7 and 10 months)
- NQ (Nijmegen questionnaire ) score(7 and 10 months)
- Epworth Sleepiness score(7 and 10 months)
- PSQI (Pittsburgh sleep quality index) score(7 and 10 months)
- HADS (Hospital Anxiety and Depression Scale) score(7 and 10 months)
- NYHA (New Year Heart Association) score(7 and 10 months)
- consumption of care(7 and 10 months)
- Number of oxygen therapy sessions followed by the patient(7 and 10 months)
研究者
研究点 (3)
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