Status:
TERMINATED
Solving Insomnia Electronically: Sleep Treatment for Asthma
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
NA
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 con...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03327519
Start Date
May 29 2018
End Date
August 15 2022
Last Update
July 21 2023
Active Locations (1)
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1
University of Pittsburgh Asthma Insititute @ UPMC
Pittsburgh, Pennsylvania, United States, 15213