NCT04012216已完成不适用
Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis: a Prospective, Predictive Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The mandibular movement respiratory disturbance index
研究概览
简要总结
The general aim of this study is to demonstrate that the measurement of respiratory effort assessed by mandibular movements during sleep is a useful measure for the screening of sleep disordered breathing (SDB) in patients with moderate to severe persistent rhinitis (R). The primary objective is therefore to determine a mandibular movement respiratory disturbance index (MM-RDI) threshold associated with a polysomnography respiratory disturbance index (PSG-RDI) ≥ 15 / h in a population of patients with moderate-to-severe persistent R.
详细描述
The secondary objectives of the study are to evaluate the concordance and correlation between:
- MM-RDI,
- the respiratory effort evaluated by MM,
- polysomnography (PSG) results,
- quality of life questionnaires,
- clinical data,
- treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patient consulting for persistant, moderate-to-severe rhinitis
- •The patient has signed the informed consent
- •The patient is a beneficiary of a social security programme (national health insurance)
- •Patient living in the Montpellier region (< 30 kilometers).
排除标准
- •The patient is participating in another study that precludes participation in the present study
- •The patient is in an exclusion period determined by another study
- •It is impossible to correctly inform the patient
- •The patient cannot fluently read French
- •Vulnerable patient populations according to French Health Code article L1121-6
- •Adult under guardianship or incapable of giving consent according to French Health Code article L1121-8
- •Pregnancy, breastfeeding (French Health Code article L1121-5)
- •Any element that renders participation in the study problematic according to the investigator
结局指标
主要结局
The mandibular movement respiratory disturbance index
时间窗: Day 7
The polysomnography respiratory disturbance index
时间窗: Day 7
次要结局
- Wake During Sleep Period(Day 7)
- Signal validity(Day 7)
- Forced vital capacity, % predicted(Day 1)
- Patient reports presence/absence of concentration difficulty(Day 1)
- The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- Patient reports presence/absence of headaches(Day 1)
- Time spent snoring(Day 7)
- Arousal index(Day 7)
- Time in sleep stage(Day 7)
- The periodic limb movement (PLM) index(Day 7)
- List of concomitant medications(Day 1)
- Epworth scale score(Day 7)
- The Pittsburgh Sleep Quality Index (PSQI)(Day 7)
- Respiratory Disturbance Index(Day 7)
- The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- Hypopnea index(Day 7)
- Apnea and Hypopnea index(Day 7)
- Number of limb movements associated with respiratory events index(Day 7)
- Photoplethysmography arousal index(Day 7)
- The Karolinska questionnaire(Day 7)
- The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)(Day 1)
- Total sleep time (TST)(Day 7)
- Mixed apnea index(Day 7)
- The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire(Day 7)
- Obstructive apnea index(Day 7)
- Apnea index(Day 7)
- Time below 90% SpO2(Day 7)
- Mean SpO2(Day 7)
- PLM arousal(Day 7)
- For asthma patients, the GINA control score(Day 1)
- The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire(Day 1)
- Respiratory effort related arousal index(Day 7)
- Oxygen desaturation ≥ 3% index(Day 7)
- Sleep Onset Latency(Day 7)
- Percentage of sleep efficiency(Day 7)
- Respiratory fragmentation of sleep index(Day 7)
- ARIA rhinitis classification(Day 1)
- Minimal SpO2 during sleep(Day 7)
- Time in bed(Day 7)
- Sleep Latency(Day 7)
- Random eye movement (REM) stage latency(Day 7)
- Percent of TST in sleep stage(Day 7)
- Arousal index associated with respiratory events(Day 7)
- TST(Day 7)
- WASO(Day 7)
- % of TST spent in respiratory effort(Day 7)
- Fragmentation of sleep index(Day 7)
- Presence/absence of asthma(Day 1)
- Forced expiratory volume in 1 second, % predicted(Day 1)
- Forced expiratory volume 25-75, % predicted predicted(Day 1)
- Patient reports presence/absence of poor sleep(Day 1)
- Patient reports presence/absence of snoring(Day 1)
- % of TST below 90% of SpO2(Day 7)
- Wake After Sleep Onset (WASO)(Day 7)
- Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted(Day 1)
- Patient reports presence/absence of dry mouth(Day 1)
- Antecedent of public road or work accident (yes/no)(Day 1)
- Allergen prick test results(Day 1)
研究者
研究点 (1)
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