Solving Insomnia Electronically: Sleep Treatment for Asthma

NCT03327519 | Terminated DMC

• 2 other identifiers: PRO17040267R01HL131587-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Insomnia

Keywords

Asthma; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Asthma Quality of Life Questionnaire (AQLQ)

  Change from Baseline to 3 & 6 months from start of intervention

• Asthma Control Test (ACT)

  Change from Baseline to 3 & 6 months from start of intervention

Study Arms (2)

SHUTi

EXPERIMENTAL

Self-guided, automated, interactive, and tailored web-based program

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.

Behavioral: Emmi

Interventions

SHUTi BEHAVIORAL

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.

SHUTi

Emmi BEHAVIORAL

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.

Emmi

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Asthma Insititute @ UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Asthma; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Faith Luyster, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: experimental, longitudinal, randomized controlled trial

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 31, 2017
• Study Start: May 29, 2018
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)