Status:

COMPLETED

Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

Lead Sponsor:

VA Office of Research and Development

Conditions:

Chronic Obstructive Pulmonary Disease

Insomnia

Eligibility:

All Genders

40+ years

Phase:

NA

Brief Summary

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based...

Detailed Description

Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL)...

Eligibility Criteria

Inclusion

  • Age 40 years and older
  • Primary diagnosis of COPD defined by GOLD
  • Meets criteria for Insomnia Disorder
  • At least moderate insomnia severity based on Insomnia Severity Index score \>7
  • Stable psychiatric and medical conditions
  • Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet

Exclusion

  • Untreated current major depression
  • Serious suicidal risk
  • Substance abuse disorder within past 3 months
  • History of bipolar or psychosis
  • Untreated restless legs syndrome, delayed sleep phase syndrome, irregular sleep schedules
  • Very severe untreated obstructive sleep apnea
  • Severe excessive daytime sleepiness based on Epworth Sleepiness Scale score \> 16
  • Restrictive lung disease (FEV1/FVC 70 and FEV1 \< 80% predicted) or asthma
  • Plans to move during the following 6 months
  • Non-English speaking or sensory deficits

Key Trial Info

Start Date :

February 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2025

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04700098

Start Date

February 14 2022

End Date

June 30 2025

Last Update

July 15 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States, 48201-1916

2

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States, 15240