Insomnia, Apnea
Conditions
Keywords
cognitive behavioral therapy, insomnia, apnea
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | Three months after randomization | 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. |
| Sleep Onset Latency From Sleep Diary | Three months after randomization | 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. |
| Wake After Sleep Onset From Sleep Diary | 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. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome. |
| Sleep Efficiency From Sleep Diary | Three months after randomization | 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. |
| Sleep Efficiency From Wrist Actigraphy | Three months after randomization | 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. |
| PAP Adherence | Three months after randomization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Treatment Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence education program provided by allied health personnel in individual sessions. | 62 |
| Active Control Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. | 63 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Refused assessment | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Behavioral Treatment | Total | Active Control |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 6.7 | 63.2 years STANDARD_DEVIATION 7.1 | 63.7 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 69 Participants | 34 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 61 Participants | 119 Participants | 58 Participants |
| Sleep efficiency from sleep diary | 70.1 percentage of time STANDARD_DEVIATION 17.8 | 70.0 percentage of time STANDARD_DEVIATION 15.9 | 69.9 percentage of time STANDARD_DEVIATION 14 |
| Sleep efficiency from wrist actigraphy | 77.7 percentage of time STANDARD_DEVIATION 9 | 77.9 percentage of time STANDARD_DEVIATION 10 | 78.1 percentage of time STANDARD_DEVIATION 10.9 |
| Sleep onset latency from diary | 40.9 minutes STANDARD_DEVIATION 41.1 | 39.3 minutes STANDARD_DEVIATION 34.7 | 37.7 minutes STANDARD_DEVIATION 27.3 |
| Sleep quality | 11.0 units on a scale STANDARD_DEVIATION 3.9 | 11.2 units on a scale STANDARD_DEVIATION 4.1 | 11.4 units on a scale STANDARD_DEVIATION 4.4 |
| Wake after sleep onset from sleep diary | 53.4 minutes STANDARD_DEVIATION 49.6 | 56.0 minutes STANDARD_DEVIATION 54.2 | 58.5 minutes STANDARD_DEVIATION 58.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 1 / 63 |
| other Total, other adverse events | 1 / 62 | 0 / 63 |
| serious Total, serious adverse events | 0 / 62 | 0 / 63 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | PAP Adherence | 38.58 number of nights | Standard Error 3.89 |
| Active Control | PAP Adherence | 21.16 number of nights | Standard Error 3.14 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | Sleep Efficiency From Sleep Diary | 86.24 percentage of time | Standard Error 1.69 |
| Active Control | Sleep Efficiency From Sleep Diary | 75.69 percentage of time | Standard Error 1.64 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | Sleep Efficiency From Wrist Actigraphy | 81.70 percentage of time | Standard Error 1.07 |
| Active Control | Sleep Efficiency From Wrist Actigraphy | 78.51 percentage of time | Standard Error 1.07 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | Sleep Onset Latency From Sleep Diary | 22.80 minutes | Standard Error 3.86 |
| Active Control | Sleep Onset Latency From Sleep Diary | 35.77 minutes | Standard Error 3.74 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | Sleep Quality | 6.25 score on a scale | Standard Error 0.56 |
| Active Control | Sleep Quality | 9.87 score on a scale | Standard Error 0.53 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment | Wake After Sleep Onset From Sleep Diary | 20.42 minutes | Standard Error 4.31 |
| Active Control | Wake After Sleep Onset From Sleep Diary | 40.67 minutes | Standard Error 4.16 |