BACKGROUND/RATIONALE:
Obstructive sleep apnea (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 decreased quality of life, increased healthcare costs and increased mortality. Recent evidence suggests that insomnia often coexists with OSA, and predicts worse outcomes of OSA. Both OSA and insomnia have an even higher prevalence among Veterans compared to the general population.

Little is known of the best approaches to manage Veterans with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) therapy is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. Adherence rates to PAP therapy in Veterans with OSA are very low, and coexisting insomnia predicts even lower adherence with PAP. Early adherence to PAP therapy is one of the strongest predictors of better long-term PAP adherence. Unfortunately, for many patients, insomnia symptoms are not addressed at all, or only considered once a long-term pattern of nonadherence with PAP is established. Based on this evidence, we developed a novel, integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy among Veterans with both insomnia and OSA.

OBJECTIVE(S):
The specific aims of this proposal were to determine:
1) whether a novel intervention combining CBT-I plus a PAP behavioral adherence program provided for Veterans with OSA and comorbid insomnia improves nighttime sleep and PAP adherence at 3-months follow-up,
2) whether the intervention improves mood and health-related quality of life at 3-months follow-up,
3) whether the intervention maintains improvements in nighttime sleep, PAP adherence, mood and health-related quality of life at 6-months follow-up, and
4) participants' experiences, attitudes and adherence with key aspects of the intervention which may act as potential facilitators or barriers to future implementation.

METHODS:
This randomized controlled trial was conducted among Veterans (aged > 50 years) referred to sleep clinics in the VA Greater Los Angeles Healthcare System for assessment of possible OSA. Veterans scheduled for an OSA assessment (i.e., in-home or in-laboratory testing) were mailed a recruitment letter with an opt-out mechanism (for those who did not wish to be contacted about the project). Telephone screening was conducted with those who did not opt-out. Veterans who met diagnostic criteria for insomnia of more than three month's duration were invited to enroll in the study. A baseline assessment was completed that included objective (i.e., wrist actigraphy) and subjective (i.e., sleep diary, Pittsburgh Sleep Quality Index [PSQI]) measures of sleep, as well as measures of depression (Patient Health Questionnaire-9, PHQ-9) and health-related quality of life (Short Form 12-version 2, SF-12v2). Participants who both met criteria for chronic insomnia, and who were subsequently diagnosed with OSA (with an apnea-hypopnea index of > 15, indicating moderate-severe OSA) and prescribed PAP therapy were randomized to the active treatment or attention control group. Both groups met individually with an interventionist for five weekly one-hour sessions.

The active treatment group combined manual-based CBT-I plus a behavioral PAP adherence program delivered by a master's-level sleep coach. The CBT-I component involved education and practical training in key aspects of stimulus control (reducing anxiety about falling asleep), sleep restriction (a structured process of reducing time spent awake in bed), sleep hygiene (establishing behavioral routines to promote restorative sleep), and cognitive therapy (addressing maladaptive beliefs about sleep). The PAP self-management component included education about OSA, problem-solving for difficulties with PAP, and managing emotional-cognitive symptoms. PAP use in the prior week was reviewed with the participant and weekly PAP use goals were established. The attention control group received non-directive, manual-based general sleep education from a master's-level individual not trained in the intervention.

Follow-up assessments were conducted at post-treatment, and at 3-months and 6-months after randomization. Primary outcomes at 3 and 6 months included sleep onset latency (SOL-d), wake after sleep onset (WASO-d) and sleep efficiency (SE-d) by sleep diary; sleep efficiency by 7-day actigraphy (SE-a); change in PSQI, PHQ-9, and SV-12v2 total scores; and modem mean hours PAP use/night (PAPhrs) and number of nights used > 4hrs (PAPnts). Analyses were intent-to-treat; mixed models with random intercepts (sleep) or t-tests (PAP adherence). After completion of the 6-month follow-up assessment, active treatment participants were invited to participate in a focus group discussion to explore participants' experience, attitudes, and adherence with the program.

FINDINGS/RESULTS:
A total of 433 subjects completed baseline assessment, of which 125 were randomized to the intervention (n=62) or control (n=63) groups. Among randomized participants, the mean age was 63 years, 96% were male, and 42% were non-Hispanic white. Intervention participants had greater improvement than controls, between baseline and 3-months, and between baseline and 6-months, in SOL-d (17 and 16 min greater improvement at 3 and 6 months, respectively), SE-d (10.7% and 8.6%), SE-a (4.3% and 2.7%), and PSQI (3.2 and 1.7); all p<.05. WASO-d improvement was greater at 3 months (20 min, p=.02) but not 6 months (15 min, p=.06). For PAP adherence, intervention group participants had more use than controls in PAPhrs (1.3 and 1.1 more hours of PAP use per night at 3 and 6-months, respectively) and PAPnts (17.4 and 11.3 more nights of PAP use over the past 90 days at 3 and 6-months, respectively); all p<.05. There were no significant differences between groups for PHQ9 and SF-12 physical and mental health scores at 3 and 6-months; all p>.05.

Three focus groups were conducted with a total of 17 active treatment participants. Overall, these participants reported that they had benefited from the education and support they received with the program. Suggestions for dissemination included conducting the program in groups, and incorporating interactions with experienced PAP users as a means to provide further encouragement and education.

IMPACT:
A behavioral treatment integrating behavioral therapy for insomnia with a PAP adherence program improved sleep and PAP adherence in Veterans with coexisting moderate-severe OSA and insomnia disorder. Integrated behavioral treatment should be considered for patients who present with coexisting OSA and insomnia.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001070-01A1
Link: https://reporter.nih.gov/project-details/8595191

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PUBLICATIONS:

Journal Articles

1. Dzierzewski JM, Martin JL, Fung CH, Song Y, Fiorentino L, Jouldjian S, Rodriguez JC, Mitchell M, Josephson K, Alessi CA. CBT for late-life insomnia and the accuracy of sleep and wake perceptions: Results from a randomized-controlled trial. Journal of Sleep Research. 2019 Aug 1; 28(4):e12809. [view]
2. Song Y, Kelly MR, Fung CH, Dzierzewski JM, Grinberg AM, Mitchell MN, Josephson K, Martin JL, Alessi CA. Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2022 Jan 1; 56(1):35-49. [view]
3. 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). [view]

DRA: Aging, Older Veterans' Health and Care, Other Conditions
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none