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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral treatment | Experimental | Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. |
|
| Active control | Active Comparator | Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insomnia treatment & PAP adherence | Behavioral | Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy Alessi, MD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27136498 | Result | 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. | |
| 33221910 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Treatment | Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. |
| FG001 | Active Control | Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Active Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | Three months after randomization |
|
Adverse event data were collected for 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Treatment | Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation from wrist actigraph band. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy Alessi, MD | VA Greater Los Angeles Healthcare System | 818-891-7711 | 39311 | Cathy.Alessi@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2015 | Feb 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| General sleep education | Behavioral | Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. |
|
| Three months after randomization |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
| West Los Angeles |
| California |
| 90073 |
| United States |
| 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. |
| Lost to Follow-up |
|
| Refused assessment |
|
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sleep quality | Total score on Pittsburgh Sleep Quality Index. Scores range from 0 to 21. Higher scores indicate worse outcome | Mean | Standard Deviation | units on a scale |
|
| Sleep onset latency from diary | Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome. | Mean | Standard Deviation | minutes |
|
| Wake after sleep onset from sleep diary | Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome. | Mean | Standard Deviation | minutes |
|
| Sleep efficiency from sleep diary | Sleep efficiency (mean percent time asleep while in bed) is calculated from 7 days of self-reported sleep diary. Higher percentages indicate better sleep outcome. | Mean | Standard Deviation | percentage of time |
|
| Sleep efficiency from wrist actigraphy | Sleep efficiency (mean percent time asleep while in bed) is calculated from 7 days of wrist actigraphy. Higher percentages indicate better sleep outcome. | Mean | Standard Deviation | percentage of time |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | minutes | Three months after randomization |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | minutes | Three months after randomization |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | percentage of time | Three months after randomization |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | percentage of time | Three months after randomization |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | number of nights | Three months after randomization |
|
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 1 |
| 62 |
| EG001 | Active Control | Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. | 1 | 63 | 0 | 63 | 0 | 63 |
|
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| D001523 |
| Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |