An interventional study of Insomnia treatment & PAP adherence and General sleep education in Insomnia and Apnea, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 125 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
Behavioral: Insomnia treatment & PAP adherence
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
Behavioral: General sleep education
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
Sleep Quality
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Time frame: Three months after randomization
Sleep Onset Latency From Sleep Diary
Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Time frame: Three months after randomization
Wake After Sleep Onset From Sleep Diary
Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Time frame: Three months after randomization
Sleep Efficiency From Sleep Diary
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Time frame: Three months after randomization
Sleep Efficiency From Wrist Actigraphy
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Time frame: Three months after randomization
PAP Adherence
Number of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Time frame: Three months after randomization
| Milestone | Behavioral Treatment | Active Control |
|---|---|---|
| Started | 62 | 63 |
| Post-treatment | 49 | 60 |
| 3-month follow-up | 53 | 58 |
| 6-month follow-up | 53 | 61 |
| Completed | 53 | 61 |
| Not completed | 9 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Refused assessment | 3 | 0 |
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
| score on a scale | Behavioral Treatment | Active Control |
|---|---|---|
| Sleep Quality | 6.25 ± 0.56 | 9.87 ± 0.53 |
Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
| minutes | Behavioral Treatment | Active Control |
|---|---|---|
| Sleep Onset Latency From Sleep Diary | 22.80 ± 3.86 | 35.77 ± 3.74 |
Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
| minutes | Behavioral Treatment | Active Control |
|---|---|---|
| Wake After Sleep Onset From Sleep Diary | 20.42 ± 4.31 | 40.67 ± 4.16 |
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
| percentage of time | Behavioral Treatment | Active Control |
|---|---|---|
| Sleep Efficiency From Sleep Diary | 86.24 ± 1.69 | 75.69 ± 1.64 |
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
| percentage of time | Behavioral Treatment | Active Control |
|---|---|---|
| Sleep Efficiency From Wrist Actigraphy | 81.70 ± 1.07 | 78.51 ± 1.07 |
Number of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
| number of nights | Behavioral Treatment | Active Control |
|---|---|---|
| PAP Adherence | 38.58 ± 3.89 | 21.16 ± 3.14 |
Collected over Adverse event data were collected for 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Treatment | 0/62 (0%) | 0/62 (0%) | 1/62 (1.6%) |
| Active Control | 1/63 (1.6%) | 0/63 (0%) | 0/63 (0%) |
| Event | Behavioral Treatment | Active Control |
|---|---|---|
| Skin irritationSkin and subcutaneous tissue disorders | 1/62 | 0/63 |
| Age, Continuous(years) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 62.8 ± 6.7 | 63.7 ± 7.6 | 63.2 ± 7.1 |
| Sex: Female, Male(Participants) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Female | 1 | 5 | 6 |
| Male | 61 | 58 | 119 |
| Race (NIH/OMB)(Participants) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 17 | 31 |
| White | 35 | 34 | 69 |
| More than one race | 4 | 6 | 10 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Sleep quality(units on a scale) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 11.0 ± 3.9 | 11.4 ± 4.4 | 11.2 ± 4.1 |
| Sleep onset latency from diary(minutes) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 40.9 ± 41.1 | 37.7 ± 27.3 | 39.3 ± 34.7 |
| Wake after sleep onset from sleep diary(minutes) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 53.4 ± 49.6 | 58.5 ± 58.7 | 56.0 ± 54.2 |
| Sleep efficiency from sleep diary(percentage of time) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 70.1 ± 17.8 | 69.9 ± 14.0 | 70.0 ± 15.9 |
| Sleep efficiency from wrist actigraphy(percentage of time) | Behavioral Treatment | Active Control | Total |
|---|---|---|---|
| Mean | 77.7 ± 9.0 | 78.1 ± 10.9 | 77.9 ± 10.0 |
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