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Solving Insomnia Electronically: Sleep Treatment for Asthma (SIESTA)

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ClinicalTrials.gov Identifier: NCT03327519
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Faith Luyster, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Asthma Insomnia Behavioral: SHUTi Behavioral: Emmi Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experimental, longitudinal, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Solving Insomnia Electronically: Sleep Treatment for Asthma
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Ilnicki, RRT, RPSGT 412.647.9955 SIESTAstudy@upmc.edu

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

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Responsible Party: Faith Luyster, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03327519     History of Changes
Other Study ID Numbers: PRO17040267
R01HL131587-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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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

Keywords provided by Faith Luyster, University of Pittsburgh:
Asthma
Insomnia

Additional relevant MeSH terms:
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Asthma
Sleep Initiation and Maintenance Disorders
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders