. Author manuscript; available in PMC: 2020 Apr 1.

Published in final edited form as: Contemp Clin Trials. 2019 Feb 27;79:73–79. doi: 10.1016/j.cct.2019.02.011

Table 2.

Inclusion and exclusion criteria.

Inclusion	Exclusion
• 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 • Clinical diagnosis of asthma supported by at least one of the following: - An increase of ≥12% and ≥ 200 ml in FEV1 after administration of albuterol during bronchodilator reversibility testing - Documented evidence of bronchodilator reversibility within 2 years prior to screening/baseline period - Documented evidence of a positive methacholine challenge test (PC20 of ≤ 16 mg) within the last 5 years • Stable doses and schedules (i.e., unchanged) of standard therapy for moderate-severe persistent asthma for 2 months prior to enrollment • FEV1 of ≥ 45% of the predicted normal value for the patient, after withholding bronchodilators • Not well-controlled asthma: Score 16–19 on Asthma Control Test • Impaired asthma-specific quality of life: Score ≤ 5 on Asthma Quality of Life Questionnaire • Meets criteria for DSM-5 Insomnia Disorder • At least moderate insomnia severity: Score > 7 on Insomnia Severity Index • Stable self-reported medical, psychiatric conditions	• Non-English speaking • Plans to move or leave present source of care during the following 8 months • Receiving antibiotics for upper respiratory infection or pulmonary condition in past 2 weeks • Heavy smoking history: Age < 30 years and smoking history > 10 pack years a OR age ≥ 30 and smoking history > 15 pack years OR smoking within past 12 months • Self-report of > 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the past 12 months • Self-reported cystic fibrosis, chronic obstructive pulmonary disease or interstitial lung disease, restless legs syndrome, bipolar disorder, or psychosis • Oral corticosteroid dosage of > 10 mg/daily • High risk for obstructive sleep apnea • Poorly controlled gastroesophageal reflux disease: Score ≥ 9 on GerdQ • Substance abuse disorder within past 3 months • Current major depression (Score ≥ 10 on Patient Health Questionnaire-9) or active suicidal ideation • Currently pregnant or trying to become pregnant

Inclusion

Exclusion

•
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
•
Clinical diagnosis of asthma supported by at least one of the following:
- -
  An increase of ≥12% and ≥ 200 ml in FEV1 after administration of albuterol during bronchodilator reversibility testing
- -
  Documented evidence of bronchodilator reversibility within 2 years prior to screening/baseline period
- -
  Documented evidence of a positive methacholine challenge test (PC20 of ≤ 16 mg) within the last 5 years
•
Stable doses and schedules (i.e., unchanged) of standard therapy for moderate-severe persistent asthma for 2 months prior to enrollment
•
FEV1 of ≥ 45% of the predicted normal value for the patient, after withholding bronchodilators
•
Not well-controlled asthma: Score 16–19 on Asthma Control Test
•
Impaired asthma-specific quality of life: Score ≤ 5 on Asthma Quality of Life Questionnaire
•
Meets criteria for DSM-5 Insomnia Disorder
•
At least moderate insomnia severity: Score > 7 on Insomnia Severity Index
•
Stable self-reported medical, psychiatric conditions

•
Non-English speaking
•
Plans to move or leave present source of care during the following 8 months
•
Receiving antibiotics for upper respiratory infection or pulmonary condition in past 2 weeks
•
Heavy smoking history: Age < 30 years and smoking history > 10 pack years a OR age ≥ 30 and smoking history > 15 pack years OR smoking within past 12 months
•
Self-report of > 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the past 12 months
•
Self-reported cystic fibrosis, chronic obstructive pulmonary disease or interstitial lung disease, restless legs syndrome, bipolar disorder, or psychosis
•
Oral corticosteroid dosage of > 10 mg/daily
•
High risk for obstructive sleep apnea
•
Poorly controlled gastroesophageal reflux disease: Score ≥ 9 on GerdQ
•
Substance abuse disorder within past 3 months
•
Current major depression (Score ≥ 10 on Patient Health Questionnaire-9) or active suicidal ideation
•
Currently pregnant or trying to become pregnant

FEV₁ forced expiratory volume in one second; PC20, provocative concentration of methacholine required to cause a 20% reduction in FEV₁.