Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAcceptance 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.
BEHAVIORALNon-directive sleep apnea education control
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group assignment.
Intervention model description
Individuals will be assigned to one of two programs simultaneously
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Community-dwelling women Veterans aged 18 years and older * Received care from a Veterans Health Administration (VHA) facility * Have a least one risk factor for sleep apnea (e.g., hypertension, obesity, or age 50 years or older) * Diagnosed as having sleep apnea with an AHI of 5 or greater
Exclusion criteria
* Currently using a treatment for sleep apnea * Current pregnancy * Active substance user or in recovery with \< 90 days of sobriety * Too ill to engage in study procedures * Do not have transportation to the medical center * Unable to self-consent (e.g., due to cognitive impairment) * Unstable housing * Does not have sleep apnea * Another sleep disorder (e.g., restless legs syndrome, circadian rhythm sleep disorder) accounts for sleep disturbance * No sleep complaints or symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAP Adherence | Three months after PAP initiation | 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. |
| Sleep Quality by Patient-reported Sleep Questionnaire | Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 46 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Refused assessment | 0 | 2 |
Baseline characteristics
| Characteristic | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 13.2 | 52.7 years STANDARD_DEVIATION 12.6 | 53.2 years STANDARD_DEVIATION 12.8 |
| Baseline AHI | 23.3 mean events per hour STANDARD_DEVIATION 15.4 | 20.5 mean events per hour STANDARD_DEVIATION 12 | 21.9 mean events per hour STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 14 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 32 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insomnia Severity Index | 15.4 units on a scale STANDARD_DEVIATION 5.7 | 12.7 units on a scale STANDARD_DEVIATION 6.3 | 14.0 units on a scale STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 10 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Female | 44 Participants | 46 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sleep Quality | 9.4 units on a scale STANDARD_DEVIATION 4.1 | 9.1 units on a scale STANDARD_DEVIATION 4.3 | 9.3 units on a scale STANDARD_DEVIATION 4.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 |
| other Total, other adverse events | 0 / 44 | 0 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 |
Outcome results
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.
Time frame: Three months after PAP initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | PAP Adherence | 32.9 Number of nights | Standard Error 4.49 |
| Non-directive Sleep Apnea Education Control | PAP Adherence | 25.67 Number of nights | Standard Error 4.03 |
p-value: 0.231395% CI: [-4.71, 19.22]t-test, 2 sided
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.
Time frame: Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Sleep Quality by Patient-reported Sleep Questionnaire | Baseline | 9.41 score on a scale | Standard Error 0.63 |
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Sleep Quality by Patient-reported Sleep Questionnaire | Three months from the date of the last intervention/control session | 6.37 score on a scale | Standard Error 0.59 |
| Non-directive Sleep Apnea Education Control | Sleep Quality by Patient-reported Sleep Questionnaire | Baseline | 9.11 score on a scale | Standard Error 0.61 |
| Non-directive Sleep Apnea Education Control | Sleep Quality by Patient-reported Sleep Questionnaire | Three months from the date of the last intervention/control session | 9.39 score on a scale | Standard Error 0.58 |
p-value: <0.00195% CI: [-4.91, -1.72]Mixed Models Analysis