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This study is a randomized controlled trial (RCT) to test two sleep apnea education programs for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway pressure (PAP) therapy. This education program is designed to improve participants' sleep quality and help them to adjust to PAP therapy.
Participants undergo a sleep and health assessment that is performed prior to beginning the education program. This assessment includes wearing a wrist actigraph to measure sleep and wake periods for 7 days and nights, and answering questionnaires about sleep habits and health. Participants are randomly assigned to one of two 6-week programs (intervention or educational control) provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week program and 3-months later. PAP usage data will be collected remotely for 6-months from PAP therapy initiation.
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. Although SDB is more common among men than women, it still impacts 17% of women in the general population. [The investigators' preliminary evidence suggests it is even more common among women Veterans who receive VA care.] The recommended first-line therapy for most patients with SDB is positive airway pressure therapy (PAP). Published studies show that women have lower PAP adherence than men, particularly in the US, yet the investigators are not aware of data comparing men and women Veterans. Because women Veterans experience significant sleep disturbance and other consequences of sleep disorders, adjusting to PAP therapy may be quite difficult. To date, studies have not tested interventions specifically designed to improve PAP adherence among women, accounting for important sleep-related and social factors.
This study is a randomized controlled trial (RCT) to test the efficacy of a program combining patient education with behavioral techniques and exercises from acceptance and commitment therapy (ACT) to improve adherence to PAP therapy. Women Veterans 18 years and older, who have received care at the VA Greater Los Angeles Healthcare System, and who have at least 1 risk factor for SDB will be recruited for this study. Screening for sleep apnea will be performed in the participant's home using a WatchPAT device. Both objective (actigraphy) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea-Hypopnea Index (AHI) of 5 or higher, and who meet all inclusion/exclusion criteria will be randomized to one of two programs: Acceptance and the Behavioral Changes to Treatment of Sleep Apnea (ABC-SA) or a non-directive sleep apnea education control.
PAP devices, along with education about SDB and sleep, will be provided to participants as part of the 6-session intervention and control programs. Follow-up assessments will be conducted immediately following the intervention/control and after 3-months.
Main study outcomes (sleep quality and PAP adherence) will be assessed 3 months after PAP initiation, and PAP adherence will be tracked remotely for 6 months. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Experimental | Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. |
|
| Non-directive sleep apnea education control | Active Comparator | Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) | Behavioral | Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. |
| Measure | Description | Time Frame |
|---|---|---|
| PAP Adherence | Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Number of nights range from 0 to 90 nights. More nights indicate better outcome. Remote monitoring data were available for all participants even if lost to follow-up for other measures. The sample size for this outcome is larger than for other outcomes as a result. | Three months after PAP initiation |
| Sleep Quality by Patient-reported Sleep Questionnaire | Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of 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. This measure is available only for participants who were not lost to follow-up. | Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session) |
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Inclusion Criteria:
Exclusion Criteria:
This study is for women Veterans.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Martin, PhD | 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 |
|---|---|---|---|
| 36525174 | Result | Moghtaderi I, Kelly MR, Carlson GC, Fung CH, Josephson KR, Song Y, Swistun D, Zhu R, Mitchell M, Lee D, Badr MS, Washington DL, Yano EM, Alessi CA, Zeidler MR, Martin JL. Identifying gaps in clinical evaluation and treatment of sleep-disordered breathing in women veterans. Sleep Breath. 2023 Oct;27(5):1929-1933. doi: 10.1007/s11325-022-02765-1. Epub 2022 Dec 16. | |
| 36764788 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Six session manual-based program using acceptance and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. |
| FG001 | Non-directive Sleep Apnea Education Control | Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Six session manual-based program using acceptance and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. |
| BG001 |
| 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 | PAP Adherence | Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Number of nights range from 0 to 90 nights. More nights indicate better outcome. Remote monitoring data were available for all participants even if lost to follow-up for other measures. The sample size for this outcome is larger than for other outcomes as a result. | Posted | Mean | Standard Error | Number of nights | Three months after PAP initiation |
|
Adverse event data were collected from enrollment and through the end of the 3-month follow-up period.
Does not differ from ClinicalTrials.gov definitions.
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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 | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA): Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth. |
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The study transitioned from in-person to telehealth visits during the COVID-19 pandemic. As a result, actigraphy could not be collected from some participants and the target sample size was not achieved for this secondary outcome. PAP devices used in the trial were recalled by the manufacturer during the final year of enrollment. Impacted participants were contacted and provided assistance. PAP devices from a different manufacturer were purchased for remaining participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Martin, PhD | VA Greater Los Angeles Healthcare System | 818-891-7711 | 36080 | jennifer.martin@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 | Feb 24, 2021 | Mar 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2020 | Mar 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Individuals will be assigned to one of two programs simultaneously
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Participants and outcome assessors will be blinded to group assignment.
|
| Non-directive sleep apnea education control | Behavioral | Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
|
| Saldana KS, McGowan SK, Martin JL. Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. Sleep Med Clin. 2023 Mar;18(1):73-83. doi: 10.1016/j.jsmc.2022.09.003. |
| 33251855 | Result | Carlson GC, Kelly MR, Grinberg AM, Mitchell M, McGowan SK, Culver NC, Kay M, Alessi CA, Washington DL, Yano EM, Martin JL. Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms. Behav Sleep Med. 2021 Sep-Oct;19(5):672-688. doi: 10.1080/15402002.2020.1846537. Epub 2020 Nov 30. |
| 34815139 | Result | Carlson GC, Kelly MR, Mitchell M, Josephson KR, McGowan SK, Culver NC, Kay M, Alessi CA, Fung CH, Washington DL, Hamilton A, Yano EM, Martin JL. Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. Womens Health Issues. 2022 Mar-Apr;32(2):194-202. doi: 10.1016/j.whi.2021.10.007. Epub 2021 Nov 21. |
| 37749876 | Result | Saldana KS, Carlson GC, Revolorio K, Kelly MR, Josephson KR, Mitchell MN, Culver N, Kay M, McGowan SK, Song Y, Deleeuw C, Martin JL. Values Expressed by Women Veterans Receiving Treatment for Chronic Insomnia Disorder. Behav Sleep Med. 2024 May-Jun;22(3):340-352. doi: 10.1080/15402002.2023.2260517. Epub 2023 Sep 25. |
| 37913677 | Result | Ravyts SG, Erickson AJ, Washington DL, Yano EM, Carlson GC, Mitchell MN, Kelly M, Alessi CA, McGowan SK, Song Y, Martin JL, Dzierzewski JM. A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. J Psychosom Res. 2023 Dec;175:111536. doi: 10.1016/j.jpsychores.2023.111536. Epub 2023 Oct 21. |
| Non-directive Sleep Apnea Education Control |
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sleep Quality | Total score on the Pittsburgh Sleep Quality Index. Scores range from 0 to 21. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline AHI | Apnea-Hypopnea Index (AHI) was calculated from overnight monitoring with a WatchPat 200 device. The AHI is the average number of apneas and hypopneas that occur per hour of sleep during the recording. An AHI > 5 is considered positive for sleep apnea. As AHI increases, the severity of sleep apnea increases. | Mean | Standard Deviation | mean events per hour |
|
| Insomnia Severity Index | Total Score on Insomnia Severity Index. Total score ranges from 0-28 where higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Non-directive Sleep Apnea Education Control |
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
|
|
|
| Primary | Sleep Quality by Patient-reported Sleep Questionnaire | Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of 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. This measure is available only for participants who were not lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session) |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Non-directive Sleep Apnea Education Control | Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. Non-directive sleep apnea education control: Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. | 0 | 46 | 0 | 46 | 0 | 46 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |