Sleep ApneaNCT03377452
Treating Sleep Apnea in Women Veterans
A study testing Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) in people with Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA), Non-directive sleep apnea education control
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)Behavioural
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 controlBehavioural
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) |
| 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. Receives: Behavioral: Non-directive sleep apnea education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start26 Jun 2018
- Primary completion31 Mar 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be assigned to one of two programs simultaneously
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer L Martin, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377452
- Sponsor's protocol ID
- IIR 16-244
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2017
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36525174Saldana 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.
PubMed 36764788Carlson 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.
PubMed 33251855Carlson 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.
PubMed 34815139Saldana 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.
PubMed 37749876Ravyts 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.
PubMed 37913677
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Sleep Apnea in Women Veterans
- ClinicalTrials.gov ID
- NCT03377452
- Acronym / sponsor ID
- IIR 16-244
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be assigned to one of two programs simultaneously
| Arm | Type | Receives |
|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Experimental | Behavioral: 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. |
| Non-directive sleep apnea education control | Active comparator | Behavioral: Non-directive sleep apnea education controlSix session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) |
| Non-directive sleep apnea education controlSix session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth. | Behavioural | Non-directive sleep apnea education control |
Primary outcome
PAP Adherence
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36525174Moghtaderi 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.
- Results publication: PubMed 36764788Saldana 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.
- Results publication: PubMed 33251855Carlson 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.
- Results publication: PubMed 34815139Carlson 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.
- Results publication: PubMed 37749876Saldana 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.
- Results publication: PubMed 37913677Ravyts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Martin, PhD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) in people with Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAP Adherence (time frame: Three months after PAP initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377452, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.