Solving Insomnia Electronically: Sleep Treatment for Asthma (SIESTA)

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia; Asthma
• Intervention / Treatment: Behavioral: SHUTi; Behavioral: Emmi

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Asthma Insititute @ UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHUTi; Self-guided, automated, interactive, and tailored web-based program	Behavioral: SHUTi; Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
Experimental: Emmi; A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.	Behavioral: Emmi; The Emmi® program for insomnia contains educational information on physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep), and sleep medications; assesses self-efficacy, and; allows patients to set individual goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Insomnia Severity Index (ISI)	The Insomnia Severity Index is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.	Change from Baseline to 3 & 6 months from start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Quality of Life Questionnaire (AQLQ)	The Asthma Quality of Life Questionnaire is a 32-item measure assessing asthma-specific health-related quality of life in 4 domains: activity limitations (ability to carry out daily activities), symptoms (frequency and nature of asthma symptoms such as coughing and chest tightness), emotional distress (intensity of the discomfort, fear, or distress associated with asthma), and environmental stimuli (capacity to manage environmental triggers of asthma such as smoke, dust, and pollution). An overall total score is computed by averaging the scores from the four domains. The total score ranges from 1 to 7, with higher scores indicating better quality of life.	Change from Baseline to 3 & 6 months from start of intervention
Asthma Control Test (ACT)	The Asthma Control Test is a 5-item questionnaire that measures asthma control by assessing interference with activity, shortness of breath, nocturnal symptoms, rescue medication use, and self-rating of asthma control. The total score ranges from 5 to 25, with higher scores indicating greater asthma control.	Change from Baseline to 3 & 6 months from start of intervention

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Faith Luyster, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Sleep Initiation and Maintenance Disorders; Asthma
• Other Study ID Numbers: PRO17040267; R01HL131587-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes