Solving Insomnia Electronically: Sleep Treatment for Asthma (SIESTA)
Primary Purpose
Asthma, Insomnia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHUTi
Emmi
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Insomnia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of moderate-severe persistent asthma
- Clinical diagnosis of asthma based on bronchodilator response or methacholine challenge testing
- Not well-controlled asthma
- Age 18-75 years
- Meets criteria for Insomnia Disorder
- At least moderate insomnia severity as evidenced by an Insomnia Severity Index score > 7
- Telephone, email address, reliable Internet access
- Stable doses and schedules (i.e., unchanged) of standard therapy for moderate to severe asthma for 2 months prior to enrollment
- Have a current primary care physician
- Stable medical, psychiatric conditions
Exclusion Criteria:
- Untreated current major depression (Patient Health Questionnaire (PHQ-9) ≥ 10); patients using stable (3 months) medication treatment are eligible
- History of bipolar or psychosis
- Substance abuse disorder within past 3 months
- Dementia or probable dementia diagnosis
- High risk for obstructive sleep apnea (OSA), restless legs syndrome (RLS), or delayed sleep phase disorder (DSPD)
- Poorly controlled gastroesophageal reflux disease (GERD): Score ≥ 9 on GERD Questionnaire.
- Use of oral corticosteroids with dosage of > 10mg/daily during ≥ 4 week period prior to Visit 1
- Heavy smoking history
- Other chronic pulmonary diseases: chronic obstructive lung disease, cystic fibrosis, or chronic bronchitis
- Patients experiencing an asthma attack/exacerbation requiring systemic corticosteroids, hospitalization or emergency room visit during screening/baseline laboratory visit
- Use of antibiotics for upper respiratory or pulmonary conditions during ≥ 2 week period prior to Visit 1
- Patients who have had > 3 asthma attacks/exacerbations requiring systemic corticosteroids, hospitalization or emergency room visit within the past year
- Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
- Plans to move during the following 6 months
- Non-English speaking, illiterate, or sensory deficits
- Currently pregnant. Participants who become pregnant during course of the study will be withdrawn from the study.
Sites / Locations
- University of Pittsburgh Asthma Insititute @ UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHUTi
Emmi
Arm Description
Self-guided, automated, interactive, and tailored web-based program
A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03327519
First Posted
October 26, 2017
Last Updated
July 19, 2023
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03327519
Brief Title
Solving Insomnia Electronically: Sleep Treatment for Asthma
Acronym
SIESTA
Official Title
Solving Insomnia Electronically: Sleep Treatment for Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
issue reaching target enrollment
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Insomnia
Keywords
Asthma, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental, longitudinal, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHUTi
Arm Type
Experimental
Arm Description
Self-guided, automated, interactive, and tailored web-based program
Arm Title
Emmi
Arm Type
Experimental
Arm Description
A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.
Intervention Type
Behavioral
Intervention Name(s)
SHUTi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emmi
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from Baseline to 3 & 6 months from start of intervention
Secondary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
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.
Time Frame
Change from Baseline to 3 & 6 months from start of intervention
Title
Asthma Control Test (ACT)
Description
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.
Time Frame
Change from Baseline to 3 & 6 months from start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Luyster, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Asthma Insititute @ UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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Solving Insomnia Electronically: Sleep Treatment for Asthma
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