AsthmaSIESTANCT03327519
Solving Insomnia Electronically: Sleep Treatment for Asthma
A study testing SHUTi and Emmi in people with Asthma and Insomnia, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- SHUTi and Emmi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Asthma Insititute @ UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Being tested
- SHUTi, Emmi
- Keywords
- Asthma, Insomnia
- Medical subject headings
- Asthma, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTiBehavioural
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.
EmmiBehavioural
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 group | Role | What they receive |
|---|---|---|
| SHUTi | Experimental | Self-guided, automated, interactive, and tailored web-based program Receives: Behavioral: SHUTi |
| Emmi | Experimental | A program that is an animated online video that walks patients through important information about a health topic, condition or procedure. Receives: Behavioral: Emmi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 3 & 6 months from start of intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline to 3 & 6 months from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start29 May 2018
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Why it stopped: issue reaching target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental, longitudinal, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Faith Luyster, University of Pittsburgh
- Investigators
- Faith Luyster, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327519
- Sponsor's protocol ID
- PRO17040267
- Other IDs
- R01HL131587-01A1
- Acronym
- SIESTA
- Status last verified
- Jul 2023
- First submitted
- 26 Oct 2017
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solving Insomnia Electronically: Sleep Treatment for Asthma
- ClinicalTrials.gov ID
- NCT03327519
- Acronym / sponsor ID
- SIESTA / PRO17040267
- Keywords
- Asthma, Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: issue reaching target enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental, longitudinal, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| SHUTi | Experimental | Behavioral: SHUTiSelf-guided, automated, interactive, and tailored web-based program |
| Emmi | Experimental | Behavioral: EmmiA program that is an animated online video that walks patients through important information about a health topic, condition or procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Self-report of current use of medications for asthma
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTiSleep 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. | Behavioural | SHUTi |
| EmmiThe 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. | Behavioural | Emmi |
Primary outcome
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.
2 secondary outcomes
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Change from Baseline to 3 & 6 months from start of intervention
Asthma Control Test (ACT)
Time frame: Change from Baseline to 3 & 6 months from start of intervention
Results and safety
The study was stopped early (reason given: issue reaching target enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faith Luyster, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi and Emmi in people with Asthma and Insomnia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: issue reaching target enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Insomnia Severity Index (ISI) (time frame: Change from Baseline to 3 & 6 months from start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.