Clinical trial NCT02027558: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
Official title: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Apnea
Keywords: cognitive behavioral therapy
insomnia
apnea
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-01-06
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and PAP adherence.

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 and PAP adherence.

Eligibility 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

Primary outcomes:
measure: Sleep Quality
timeFrame: Three months after randomization
measure: Sleep Onset Latency From Sleep Diary
timeFrame: Three months after randomization
measure: Wake After Sleep Onset From Sleep Diary
timeFrame: Three months after randomization
measure: Sleep Efficiency From Sleep Diary
timeFrame: Three months after randomization
measure: Sleep Efficiency From Wrist Actigraphy
timeFrame: Three months after randomization
measure: PAP Adherence
timeFrame: Three months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Cathy Alessi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fung CH, Martin JL, Josephson K, Fiorentino L, Dzierzewski JM, Jouldjian S, Tapia JC, Mitchell MN, Alessi C. Efficacy of Cognitive Behavioral Therapy for Insomnia in Older Adults With Occult Sleep-Disordered Breathing. Psychosom Med. 2016 Jun;78(5):629-39. doi: 10.1097/PSY.0000000000000314.
citation: Alessi CA, Fung CH, Dzierzewski JM, Fiorentino L, Stepnowsky C, Rodriguez Tapia JC, Song Y, Zeidler MR, Josephson K, Mitchell MN, Jouldjian S, Martin JL. Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea. Sleep. 2021 Apr 9;44(4):zsaa235. doi: 10.1093/sleep/zsaa235.