Overview

The Solving Insomnia Electronically: Sleep Treatment for Asthma study aims to determine the association between sleep and asthma control, as adults with asthma often report suffering from insomnia. 

Study Information 

During the study, patients will watch either a video program about insomnia (Emmi) or participate in a web-based behavioral program that aims to improve sleep quality (SHUTi). 

Inclusion Criteria:

• Diagnosed with moderate or severe persistent asthma
• Has received a clinical diagnosis of asthma based on bronchodilator response or methacholine challenge testing
• Poorly controlled asthma
• Aged 18-75 years
• Meets the criteria for insomnia disorder
• Has an insomnia severity score of above 7 (moderate)
• Has access to reliable telephone and internet as well as an email address
• Has received standard therapy for moderate to severe asthma in the 2 months leading up to study enrollment
• Currently has a primary care physician
• If the participant has medical or psychiatric conditions, they must be stable

Exclusion Criteria:

• Suffers from untreated major depression (Patient Health Questionnaire (PHQ-9) ≥ 10). 
• Has a history of bipolar or psychosis
• Has suffered from substance abuse disorder in the past 3 months
• Diagnosed with dementia or probable dementia
• Is at high risk for obstructive sleep apnea (OSA), restless leg syndrome (RLS), or delayed sleep phase disorder (DSPD)
• Poorly controlled gastroesophageal reflux disease (GERD): A score of  ≥ 9 on the GERD Questionnaire.
• Takes > 10mg/daily of oral corticosteroids during ≥ 4 week period prior to Visit 1
• History of heavy smoking 
• Has chronic obstructive lung disease, cystic fibrosis, or chronic bronchitis
• Has experienced an asthma attack requiring systemic corticosteroids, hospitalization or emergency room visit during screening or the baseline laboratory visit
• Uses antibiotics  to treat upper respiratory or pulmonary conditions during ≥ 2 week period prior to Visit 1
• Has had more than 3 asthma attacks requiring systemic corticosteroids, hospitalization or emergency room visit during the past year
• Works shifts between the hours of 12:00 a.m. – 6:00 a.m.
• Has plans to relocate during the following 6 months
• Does not speak English or is illiterate 
• Is currently pregnant. Patients who become pregnant during the course of the study will be unable to participate further.

Locations

University of Pittsburgh Asthma Institute @ UPMC

Pittsburgh, Pennsylvania, United States

Sponsors / Collaborators

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)