Solving Insomnia Electronically: Sleep Treatment for Asthma

Asthma Clinical Trial

— SIESTA  

Official title:

Solving Insomnia Electronically: Sleep Treatment for Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03327519
• Other study ID #: PRO17040267
• Secondary ID: R01HL131587-01A1
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: August 15, 2022

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 educational video about insomnia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years

2. Telephone, email address, reliable Internet access

3. Have a current primary care physician or a physician who is managing patient's asthma

4. Diagnosis of asthma supported by at least one of the following:

1. Patient self-report of physician diagnosis of asthma

2. Asthma diagnosis in the electronic medical record

5. Self-report of current use of medications for asthma

6. 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

7. 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.

8. Impaired asthma-specific quality of life: Score = 5 on Asthma Quality of Life Questionnaire

9. 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.

10. Meets criteria for DSM-5 Insomnia Disorder

11. At least moderate insomnia severity: Score > 7 on Insomnia Severity Index

12. Stable self-reported medical, psychiatric conditions

Exclusion Criteria:

1. Non-English speaking, illiterate, or sensory deficits

2. Plans to move or leave present source of care during the following 8 months

3. Receiving antibiotics for upper respiratory infection or pulmonary condition in previous 2 weeks

4. 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

5. Substance abuse disorder within previous 3 months

6. Self-reported cystic fibrosis, COPD or interstitial lung disease

7. Self-report of > 3 asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous year

8. Oral corticosteroid dosage of > 10 mg/daily

9. Poorly controlled gastroesophageal reflux disease (GERD)

10. Untreated severe obstructive sleep apnea based on apnea-hypopnea index of = 55

11. Self-reported untreated restless legs syndrome

12. History of bipolar disorder or psychosis

13. Current major depression or active suicidal ideation.

14. Asthma attacks/exacerbations requiring systemic corticosteroids, emergency room visit, or hospitalization within the previous 4 weeks

15. 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.

16. Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)

17. Enrolled in prior R03 study (HL135213)

Related Conditions & MeSH terms

• Asthma
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Asthma Insititute @ UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to 3 & 6 months from start of intervention
Secondary	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.	Change from Baseline to 3 & 6 months from start of intervention
Secondary	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.	Change from Baseline to 3 & 6 months from start of intervention