SIESTA: Solving Insomnia Electronically: Sleep Treatment for Asthma
Study Details
Study Description
Brief Summary
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHUTi Self-guided, automated, interactive, and tailored web-based program |
Behavioral: SHUTi
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.
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| Experimental: Emmi A program that is an animated online video that walks patients through important information about a health topic, condition or procedure. |
Behavioral: Emmi
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.
|
Outcome Measures
Primary Outcome Measures
- The Insomnia Severity Index (ISI) [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.
Secondary Outcome Measures
- Asthma Quality of Life Questionnaire (AQLQ) [Change from Baseline to 3 & 6 months from start of intervention]
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.
- Asthma Control Test (ACT) [Change from Baseline to 3 & 6 months from start of intervention]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of moderate-severe persistent asthma
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Clinical diagnosis of asthma based on bronchodilator response or methacholine challenge testing
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Not well-controlled asthma
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Age 18-75 years
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Meets criteria for Insomnia Disorder
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At least moderate insomnia severity as evidenced by an Insomnia Severity Index score > 7
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Telephone, email address, reliable Internet access
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Stable doses and schedules (i.e., unchanged) of standard therapy for moderate to severe asthma for 2 months prior to enrollment
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Have a current primary care physician
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Stable medical, psychiatric conditions
Exclusion Criteria:
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Untreated current major depression (Patient Health Questionnaire (PHQ-9) ≥ 10); patients using stable (3 months) medication treatment are eligible
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History of bipolar or psychosis
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Substance abuse disorder within past 3 months
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Dementia or probable dementia diagnosis
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High risk for obstructive sleep apnea (OSA), restless legs syndrome (RLS), or delayed sleep phase disorder (DSPD)
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Poorly controlled gastroesophageal reflux disease (GERD): Score ≥ 9 on GERD Questionnaire.
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Use of oral corticosteroids with dosage of > 10mg/daily during ≥ 4 week period prior to Visit 1
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Heavy smoking history
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Other chronic pulmonary diseases: chronic obstructive lung disease, cystic fibrosis, or chronic bronchitis
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Patients experiencing an asthma attack/exacerbation requiring systemic corticosteroids, hospitalization or emergency room visit during screening/baseline laboratory visit
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Use of antibiotics for upper respiratory or pulmonary conditions during ≥ 2 week period prior to Visit 1
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Patients who have had > 3 asthma attacks/exacerbations requiring systemic corticosteroids, hospitalization or emergency room visit within the past year
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Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
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Plans to move during the following 6 months
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Non-English speaking, illiterate, or sensory deficits
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Currently pregnant. Participants who become pregnant during course of the study will be withdrawn from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Asthma Insititute @ UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Faith Luyster, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO17040267
- R01HL131587-01A1