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Solving Insomnia Electronically: Sleep Treatment for Asthma (SIESTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327519
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Faith Luyster, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
The Insomnia Severity Index (ISI) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
The Insomnia Severity Index (ISI) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
    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) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
  • Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
    The AQLQ is a 32-item measure assessing condition-specific health-related quality of life.
  • Asthma Control Test (ACT) [ Time Frame: Change from Baseline to 3 & 6 months from start of intervention ]
    The ACT is a 5-item questionnaire that assesses interference with activity, shortness of breath, nocturnal symptoms, rescue medication use, and self-rating of asthma control.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Solving Insomnia Electronically: Sleep Treatment for Asthma
Official Title  ICMJE Solving Insomnia Electronically: Sleep Treatment for Asthma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
experimental, longitudinal, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Insomnia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: SHUTi
    Self-guided, automated, interactive, and tailored web-based program
    Intervention: Behavioral: SHUTi
  • Experimental: Emmi
    A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.
    Intervention: Behavioral: Emmi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2017)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of moderate-severe persistent asthma
  2. Clinical diagnosis of asthma based on bronchodilator response or methacholine challenge testing
  3. Not well-controlled asthma
  4. Age 18-75 years
  5. Meets criteria for Insomnia Disorder
  6. At least moderate insomnia severity as evidenced by an Insomnia Severity Index score > 7
  7. Telephone, email address, reliable Internet access
  8. Stable doses and schedules (i.e., unchanged) of standard therapy for moderate to severe asthma for 2 months prior to enrollment
  9. Have a current primary care physician
  10. Stable medical, psychiatric conditions

Exclusion Criteria:

  1. Untreated current major depression (Patient Health Questionnaire (PHQ-9) ≥ 10); patients using stable (3 months) medication treatment are eligible
  2. History of bipolar or psychosis
  3. Substance abuse disorder within past 3 months
  4. Dementia or probable dementia diagnosis
  5. High risk for obstructive sleep apnea (OSA), restless legs syndrome (RLS), or delayed sleep phase disorder (DSPD)
  6. Poorly controlled gastroesophageal reflux disease (GERD): Score ≥ 9 on GERD Questionnaire.
  7. Use of oral corticosteroids with dosage of > 10mg/daily during ≥ 4 week period prior to Visit 1
  8. Heavy smoking history
  9. Other chronic pulmonary diseases: chronic obstructive lung disease, cystic fibrosis, or chronic bronchitis
  10. Patients experiencing an asthma attack/exacerbation requiring systemic corticosteroids, hospitalization or emergency room visit during screening/baseline laboratory visit
  11. Use of antibiotics for upper respiratory or pulmonary conditions during ≥ 2 week period prior to Visit 1
  12. Patients who have had > 3 asthma attacks/exacerbations requiring systemic corticosteroids, hospitalization or emergency room visit within the past year
  13. Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
  14. Plans to move during the following 6 months
  15. Non-English speaking, illiterate, or sensory deficits
  16. Currently pregnant. Participants who become pregnant during course of the study will be withdrawn from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa Ilnicki, RRT, RPSGT 412.647.9955 SIESTAstudy@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327519
Other Study ID Numbers  ICMJE PRO17040267
R01HL131587-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Faith Luyster, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Faith Luyster, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP