NCT03327519终止不适用
Solving Insomnia Electronically: Sleep Treatment for Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The Insomnia Severity Index (ISI)
研究概览
简要总结
Insomnia is commonly reported by adults with asthma. Insomnia can worsen asthma patients' quality of life and increase the risk for asthma attacks.This clinical trial will compare sleep and asthma control in adults with asthma and insomnia who receive either an internet-based intervention for insomnia or an educational video about insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Telephone, email address, reliable Internet access
- •Have a current primary care physician or a physician who is managing patient's asthma
- •Diagnosis of asthma supported by at least one of the following:
- •Patient self-report of physician diagnosis of asthma
- •Asthma diagnosis in the electronic medical record
- •Self-report of current use of medications for asthma
- •FEV1 of ≥ 45% of the predicted normal value for the patient, after withholding bronchodilators at or personal best peak expiratory flow of > 100 L/min
- •Not well-controlled asthma: Score 12-19 on Asthma Control Test for those on an inhaled corticosteroid; Score 16-19 on Asthma Control Test for those not on an inhaled corticosteroid.
- •Impaired asthma-specific quality of life: Score ≤ 5 on Asthma Quality of Life Questionnaire
- •If subjects are on a controller medication (i.e., inhaled corticosteroid, inhaled corticosteroid and long acting beta-agonists, Singulair, etc.), they must be on stable doses and schedules (i.e., unchanged) of therapy for 2 months prior to enrollment.
- •Meets criteria for DSM-5 Insomnia Disorder
- •At least moderate insomnia severity: Score > 7 on Insomnia Severity Index
- •Stable self-reported medical, psychiatric conditions
排除标准
- •Non-English speaking, illiterate, or sensory deficits
- •Plans to move or leave present source of care during the following 8 months
- •Receiving antibiotics for upper respiratory infection or pulmonary condition in previous 2 weeks
- •Heavy smoking: Age < 30 years and smoking history > 10 pack years OR age ≥ 30 and smoking history > 15 pack years OR smoking within previous 12 months
- •Substance abuse disorder within previous 3 months
- •Self-reported cystic fibrosis, COPD or interstitial lung disease
- •Self-report of > 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous year
- •Oral corticosteroid dosage of > 10 mg/daily
- •Poorly controlled gastroesophageal reflux disease (GERD)
- •Untreated severe obstructive sleep apnea based on apnea-hypopnea index of ≥ 55
- •Self-reported untreated restless legs syndrome
- •History of bipolar disorder or psychosis
- •Current major depression or active suicidal ideation.
- •Asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous 4 weeks
- •Self-report of current pregnancy or trying to become pregnant. Participants who become pregnant during course of the study will be withdrawn from the study.
- •Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
- •Enrolled in prior R03 study (HL135213)
结局指标
主要结局
The Insomnia Severity Index (ISI)
时间窗: Change from Baseline to 3 & 6 months from start of intervention
The Insomnia Severity Index is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.
次要结局
- Asthma Quality of Life Questionnaire (AQLQ)(Change from Baseline to 3 & 6 months from start of intervention)
- Asthma Control Test (ACT)(Change from Baseline to 3 & 6 months from start of intervention)
研究者
Faith Luyster
Associate Professor
University of Pittsburgh
研究点 (2)
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