Solving Insomnia Electronically: Sleep Treatment for Asthma (SIESTA)

University of Pittsburgh

Status

Terminated

Conditions

Asthma

Insomnia

Treatments

Behavioral: SHUTi

Behavioral: Emmi

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03327519

R01HL131587-01A1 (U.S. NIH Grant/Contract)

PRO17040267

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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:
1. Patient self-report of physician diagnosis of asthma
2. 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)