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Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

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ClinicalTrials.gov Identifier: NCT02027558
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime sleep, PAP adherence, mood and health-related quality of life.

Condition or disease Intervention/treatment Phase
Insomnia Apnea Behavioral: Behavioral Education Intervention I Behavioral: Behavioral Education Intervention II Not Applicable

Detailed Description:

Sleep disturbance is common in older adults and is associated with increased healthcare utilization, more depressive symptoms, and other adverse effects on health-related quality of life. Obstructive sleep apnea (OSA) is a disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. OSA increases in prevalence with age, and is associated with increased risk of cardiovascular disease, decreased quality of life, and increased mortality. Insomnia also increases in prevalence with age, and is associated with numerous adverse outcomes, including cognitive decline, decreased quality of life, increased healthcare costs and increased mortality. The diagnostic criteria for insomnia include a decreased ability to fall asleep or stay asleep, frequent nighttime awakening or poor quality sleep that is associated with daytime impairment such as fatigue, impaired attention, or daytime sleepiness. Increasing evidence suggests that insomnia often coexists with OSA, particularly in older adults, and predicts worse outcomes of OSA. Both OSA and insomnia have a higher prevalence among Veterans, compared to the general population.

Little is known of the best approaches to manage the large number of patients with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. CBT-I is particularly recommended for insomnia in older adults, where adverse effects of sleeping medications are most problematic. Early adherence to PAP therapy (i.e., within the first week of PAP therapy) is one of the strongest predictors of long-term PAP adherence. However, adherence rates to PAP therapy in patients with OSA are low. In addition, CBT-I has not been widely implemented for treatment of insomnia (in part due to limited access to mental health specialists able to provide CBT-I), untreated OSA limits response to treatment of insomnia, and untreated insomnia negatively impacts PAP adherence.

Based on this evidence and findings from the investigators' prior work, the investigators believe that an integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy is needed to maximize patient adherence and treatment success when these conditions coexist. The investigators propose a randomized controlled trial to test a novel, behavioral approach integrating best practices for management of both conditions among older Veterans with OSA who are prescribed PAP therapy and have comorbid insomnia. The purpose of this project is to determine whether this intervention improves nighttime sleep, PAP adherence, mood and health-related quality of life.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Behavioral Education Intervention
Manual-based education program focusing on sleep and sleep apnea provided by allied health personnel in individual sessions.
Behavioral: Behavioral Education Intervention I
Manual-based education program focusing on sleep and sleep apnea provided by allied health personnel in individual sessions.
Experimental: Behavioral Education Intervention II
Manual-based education program focusing on sleep and sleep apnea provided by allied health personnel in individual sessions.
Behavioral: Behavioral Education Intervention II
Manual-based education program focusing on sleep and sleep apnea provided by allied health personnel in individual sessions.



Primary Outcome Measures :
  1. Sleep quality [ Time Frame: Three months after randomization ]
    Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality.

  2. PAP adherence (hours of use per night from remote monitoring) [ Time Frame: Three months after randomization ]
    Hours of nightly PAP use will be measured using data gathered from the PAP equipment.

  3. Sleep efficiency from sleep diary [ Time Frame: Three months after randomization ]
    Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.

  4. Wake after sleep onset from sleep diary [ Time Frame: Three months after randomization ]
    Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary.

  5. Sleep onset latency from sleep diary [ Time Frame: Three months after randomization ]
    Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary.

  6. Sleep efficiency from wrist actigraphy [ Time Frame: Three months after randomization ]
    Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets diagnostic criteria for insomnia
  • Diagnosis of obstructive sleep apnea (AHI > or = 15) and prescription of PAP therapy
  • Age > or =50
  • Community-dwelling
  • Live within a 30-mile radius of VA GLAHS
  • Have transportation to VA GLAHS to attend the intervention/control programs

Exclusion Criteria:

  • Significant cognitive impairment (MMSE < 24)
  • History of mania, major psychopathology or a psychiatric hospitalization in prior two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027558


Locations
United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Cathy Alessi, MD VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02027558     History of Changes
Other Study ID Numbers: IIR 12-353
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
cognitive behavioral therapy
insomnia
apnea

Additional relevant MeSH terms:
Apnea
Sleep Initiation and Maintenance Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders