Solving Insomnia Electronically: Sleep Treatment for Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Solving Insomnia Electronically: Sleep Treatment for Asthma

Conditions
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Asthma, Insomnia

Intervention / Treatment
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* Behavioral: SHUTi
* Behavioral: Emmi


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: experimental, longitudinal, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHUTi<br>Self-guided, automated, interactive, and tailored web-based program | Behavioral: SHUTi<br>* 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.<br>|
| Experimental: Emmi<br>A program that is an animated online video that walks patients through important information about a health topic, condition or procedure. | Behavioral: Emmi<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Insomnia