Treating Sleep Apnea in Women Veterans
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2018 |
| Start Date: | June 26, 2018 |
| End Date: | January 31, 2022 |
| Contact: | Jennifer L Martin, PhD |
| Email: | jennifer.martin@va.gov |
| Phone: | (818) 891-7711 |
Diagnosis and Treatment of Sleep Apnea in Women Veterans
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 will undergo a sleep and health assessment that will be 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 will be randomly assigned to one of two 6-week
education programs provided by a study interventionist. Follow-up sleep and health
assessments will be conducted at the end of the 6-week education program and 3-months later.
PAP usage data will be collected remotely for 12 months from PAP therapy initiation.
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 will undergo a sleep and health assessment that will be 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 will be randomly assigned to one of two 6-week
education programs provided by a study interventionist. Follow-up sleep and health
assessments will be conducted at the end of the 6-week education program and 3-months later.
PAP usage data will be collected remotely for 12 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 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 AHI of 5 or
higher, and who meet all inclusion/exclusion criteria will be randomized to one of two
educational programs.
PAP devices, along with education about SDB and insomnia, will be provided to participants as
part of the 6-session intervention. Follow-up assessments will be conducted immediately
following the intervention 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 12 months. Data will be analyzed
using "intention to treat" principles, using appropriate statistical methods for clinical
trials.
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 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 AHI of 5 or
higher, and who meet all inclusion/exclusion criteria will be randomized to one of two
educational programs.
PAP devices, along with education about SDB and insomnia, will be provided to participants as
part of the 6-session intervention. Follow-up assessments will be conducted immediately
following the intervention 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 12 months. Data will be analyzed
using "intention to treat" principles, using appropriate statistical methods for clinical
trials.
Inclusion Criteria:
- Community-dwelling women Veterans aged 18 years and older
- Received care from a 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
We found this trial at
1
site
Sepulveda, California 91343
Phone: 310-268-4437
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