Clinical trial NCT03327519: Solving Insomnia Electronically: Sleep Treatment for Asthma
Official title: Solving Insomnia Electronically: Sleep Treatment for Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Insomnia
Keywords: Asthma
Insomnia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-10-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental, longitudinal, randomized controlled trial
Primary purpose: TREATMENT

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 control in adults with asthma and insomnia who receive either an internet-based intervention for insomnia or an educational video about insomnia.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years
2. Telephone, email address, reliable Internet access
3. Have a current primary care physician or a physician who is managing patient's asthma
4. 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
5. Self-report of current use of medications for asthma
6. 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
7. 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.
8. Impaired asthma-specific quality of life: Score ≤ 5 on Asthma Quality of Life Questionnaire
9. 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.
10. Meets criteria for DSM-5 Insomnia Disorder
11. At least moderate insomnia severity: Score \> 7 on Insomnia Severity Index
12. Stable self-reported medical, psychiatric conditions

Exclusion Criteria:

1. Non-English speaking, illiterate, or sensory deficits
2. Plans to move or leave present source of care during the following 8 months
3. Receiving antibiotics for upper respiratory infection or pulmonary condition in previous 2 weeks
4. 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
5. Substance abuse disorder within previous 3 months
6. Self-reported cystic fibrosis, COPD or interstitial lung disease
7. Self-report of \> 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous year
8. Oral corticosteroid dosage of \> 10 mg/daily
9. Poorly controlled gastroesophageal reflux disease (GERD)
10. Untreated severe obstructive sleep apnea based on apnea-hypopnea index of ≥ 55
11. Self-reported untreated restless legs syndrome
12. History of bipolar disorder or psychosis
13. Current major depression or active suicidal ideation.
14. Asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous 4 weeks
15. 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.
16. Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
17. Enrolled in prior R03 study (HL135213)

Primary outcomes:
measure: The Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to 3 & 6 months from start of intervention
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Change from Baseline to 3 & 6 months from start of intervention
measure: Asthma Control Test (ACT)
timeFrame: Change from Baseline to 3 & 6 months from start of intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Asthma Insititute @ UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Faith Luyster, PhD
role: PRINCIPAL_INVESTIGATOR
References: