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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL131587-01A1 | U.S. NIH Grant/Contract | View source |
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issue reaching target enrollment
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHUTi | Experimental | Self-guided, automated, interactive, and tailored web-based program |
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| Emmi | Experimental | A program that is an animated online video that walks patients through important information about a health topic, condition or procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHUTi | Behavioral | Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| The Insomnia Severity Index (ISI) | 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. | Change from Baseline to 3 & 6 months from start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Quality of Life Questionnaire (AQLQ) | The Asthma Quality of Life Questionnaire is a 32-item measure assessing asthma-specific health-related quality of life in 4 domains: activity limitations (ability to carry out daily activities), symptoms (frequency and nature of asthma symptoms such as coughing and chest tightness), emotional distress (intensity of the discomfort, fear, or distress associated with asthma), and environmental stimuli (capacity to manage environmental triggers of asthma such as smoke, dust, and pollution). An overall total score is computed by averaging the scores from the four domains. The total score ranges from 1 to 7, with higher scores indicating better quality of life. |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faith Luyster, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Asthma Insititute @ UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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experimental, longitudinal, randomized controlled trial
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| Emmi | Behavioral | The Emmi® program for insomnia contains educational information on physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep), and sleep medications; assesses self-efficacy, and; allows patients to set individual goals. |
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| Change from Baseline to 3 & 6 months from start of intervention |
| Asthma Control Test (ACT) | The Asthma Control Test is a 5-item questionnaire that measures asthma control by assessing interference with activity, shortness of breath, nocturnal symptoms, rescue medication use, and self-rating of asthma control. The total score ranges from 5 to 25, with higher scores indicating greater asthma control. | Change from Baseline to 3 & 6 months from start of intervention |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |