Solving Insomnia Electronically: Sleep Treatment for Asthma

Not Applicable

Terminated

• Conditions: Asthma; Insomnia
• Interventions: Behavioral: Emmi; Behavioral: SHUTi

• Registration Number: NCT03327519
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Study Start: 2018-05-29
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emmi	Emmi	A program that is an animated online video that walks patients through important information about a health topic, condition or procedure.
SHUTi	SHUTi	Self-guided, automated, interactive, and tailored web-based program

Primary Outcome Measures

Name	Time	Method
The Insomnia Severity Index (ISI)	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

Name	Time	Method
Asthma Quality of Life Questionnaire (AQLQ)	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)	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.

Trial Locations

Locations (1)

University of Pittsburgh Asthma Insititute @ UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States