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 : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Asthma Insomnia||Behavioral: SHUTi Behavioral: Emmi||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||experimental, longitudinal, randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Solving Insomnia Electronically: Sleep Treatment for Asthma|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Self-guided, automated, interactive, and tailored web-based program
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.
A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327519
|Contact: Melissa Ilnicki, RRT, RPSGT||412.647.9955||SIESTAstudy@upmc.edu|
|United States, Pennsylvania|
|University of Pittsburgh Asthma Insititute @ UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Melissa Ilnicki, RRT, RPSGT 412-647-9955 SIESTAstudy@upmc.edu|
|Principal Investigator: Faith Luyster, PhD|
|Principal Investigator:||Faith Luyster, PhD||University of Pittsburgh|