Sleep ApneaCPAPPsNCT01164683
A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
A study testing Peer-driven intervention in people with Sleep Apnea, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Peer-driven intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obstructive Sleep Apnea (defined by Apnea-hypopnea index [AHI] > 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography.
- Age range 21 - 85 years old.
- Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months.
- No regular use (> 3 times/week) of sedative or hypnotic medications in the last 4 months.
Who cannot join
- Central sleep apnea (central apnea index > 5 per hour and >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
- Complex sleep apnea or CPAP emergent central apnea (Central apnea index > 5 per hour during CPAP titration with >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
- Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation.
- Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease
- Chronic narcotic use
- Nasal obstruction (nasal congestion score > 15) or enlarged tonsils
Show all 12Show fewer
- Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder [ 15 limb movements/hour of sleep with arousal], central sleep apnea [ 50% of apneas on diagnostic PSG are central apneas], insomnia, obesity hypoventilation syndrome, or narcolepsy).
- Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA.
- Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months.
- Routine consumption of more than 2 alcoholic beverages per day.
- Recent or recurring history of recreational drug use leading to tolerance or dependence.
- Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
About this study
Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. The investigators plan to improve CPAP adherence in veterans through their interactions with peers who have successfully adopted CPAP therapy.
Such "peer-buddies" may promote the well-being of veterans while remaining highly cost-effective when compared to healthcare providers. Our strategy is grounded on the rationale that veterans as a group are ecoculturally more homogenous than expected for the given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and exportable system of care to promote CPAP adherence in patients with OSA.
Read the detailed description
Project background: Obstructive sleep apnea (OSA) is a prevalent condition that is most frequently treated with continuous positive airway pressure (CPAP) therapy. Non-adherence to such therapy, however, afflicts a high proportion of adults with sleep apnea (46-83%). Moreover, such non-adherence to CPAP is associated with increased risk for fatal and non-fatal cardiovascular events. There remains a paucity of reliable and cost-effective interventions that could promote CPAP adherence. Promoting adherence to therapy through peer-driven intervention is cheap and has met with modest success in other chronic conditions such as HIV, heart failure and diabetes mellitus. Whether such a peer-driven ("buddy") system can improve adherence to CPAP therapy is unknown.
Project Objectives: Our overall aim is to assess the feasibility and acceptability of a CPAP adherence program driven by trained "peer-buddies" with sleep apnea. Specific Objective #1: To evaluate patient ratings of the acceptability of the peer buddy system (PBS) in veterans receiving CPAP therapy for OSA. Specific Objective #2: To obtain preliminary data on the effectiveness of PBS on sleep-specific HR-QOL (Functional outcomes in sleep questionnaire [FOSQ]) in veterans receiving CPAP therapy for OSA. Specific Objective #3: To obtain preliminary data on the effect of PBS on CPAP adherence, vigilance, patient activation, and self-efficacy in veterans receiving CPAP therapy for OSA.
Project Methods: In order to address these aims, we will recruit recently diagnosed patients with OSA who have not been initiated on CPAP therapy and randomly assign them to the peer-buddy system to promote adherence to CPAP therapy (intervention group) or be assigned to usual care (control group). In the PBS intervention group, trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3- month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). The interaction will occur during supervised "in-person" sessions and during telephonic conversations over the 3-month period. Subjects from both groups will be reassessed at the end of 3 months in order to determine objective measures of CPAP adherence, sleep-specific HRQOL Functional outcomes of sleep questionnaire [FOSQ]), vigilance (psychomotor vigilance testing), measures of self-efficacy (outcome expectancy, treatment self-efficacy, and risk perception [SEMSA questionnaire]) and patient activation (Patient Activation Measure [PAM]).
- Conditions
- Sleep Apnea
- Being tested
- Peer-driven intervention, Usual Care
- Keywords
- sleep apnea, adherence
- 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.
Peer-driven interventionBehavioural
Also called Peer-buddy system (PBS)
Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).
Usual CareOther
All participants will receive usual care following initiation of CPAP therapy. Visits with respiratory therapist and sleep physician wherein patients are educated about the basics of the care and operation of the device, mask and related equipment. Subsequently, their CPAP adherence is monitored and appropriate interventions such as mask change and re-education undertaken as needed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). Receives: Behavioral: Peer-driven intervention |
| Arm 2 | Active comparator | Usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcomes of Sleep Questionnaire (FOSQ)
Measured: Three months
Secondary outcomes (6)
CPAP adherence
Measured: Three months
Patient Activation Measure (PAM) survey assessment tool
Measured: Three months
Self efficacy measure for sleep apnea
Measured: Three months
Psychomotor vigilance test
Measured: three months
Patient acceptability of peer-based intervention
Measured: Three months
Epworth sleepiness score
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, Southern Arizona VA Health Care System, Tucson, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164683
- Sponsor's protocol ID
- PPO 10-066
- Acronym
- CPAPPs
- Status last verified
- Feb 2013
- First submitted
- 15 Jun 2010
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Parthasarathy S. The need for pharmacovigilance in sleep medicine. Sleep. 2011 Jul 1;34(7):827-8. doi: 10.5665/SLEEP.1096. No abstract available.
PubMed 21731126Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.
PubMed 23772186
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
- ClinicalTrials.gov ID
- NCT01164683
- Acronym / sponsor ID
- CPAPPs / PPO 10-066
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. The investigators plan to improve CPAP adherence in veterans through their interactions with peers who have successfully adopted CPAP therapy.
Such "peer-buddies" may promote the well-being of veterans while remaining highly cost-effective when compared to healthcare providers. Our strategy is grounded on the rationale that veterans as a group are ecoculturally more homogenous than expected for the given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and exportable system of care to promote CPAP adherence in patients with OSA.
Detailed description
Project background: Obstructive sleep apnea (OSA) is a prevalent condition that is most frequently treated with continuous positive airway pressure (CPAP) therapy. Non-adherence to such therapy, however, afflicts a high proportion of adults with sleep apnea (46-83%). Moreover, such non-adherence to CPAP is associated with increased risk for fatal and non-fatal cardiovascular events. There remains a paucity of reliable and cost-effective interventions that could promote CPAP adherence. Promoting adherence to therapy through peer-driven intervention is cheap and has met with modest success in other chronic conditions such as HIV, heart failure and diabetes mellitus. Whether such a peer-driven ("buddy") system can improve adherence to CPAP therapy is unknown.
Project Objectives: Our overall aim is to assess the feasibility and acceptability of a CPAP adherence program driven by trained "peer-buddies" with sleep apnea. Specific Objective #1: To evaluate patient ratings of the acceptability of the peer buddy system (PBS) in veterans receiving CPAP therapy for OSA. Specific Objective #2: To obtain preliminary data on the effectiveness of PBS on sleep-specific HR-QOL (Functional outcomes in sleep questionnaire [FOSQ]) in veterans receiving CPAP therapy for OSA. Specific Objective #3: To obtain preliminary data on the effect of PBS on CPAP adherence, vigilance, patient activation, and self-efficacy in veterans receiving CPAP therapy for OSA.
Project Methods: In order to address these aims, we will recruit recently diagnosed patients with OSA who have not been initiated on CPAP therapy and randomly assign them to the peer-buddy system to promote adherence to CPAP therapy (intervention group) or be assigned to usual care (control group). In the PBS intervention group, trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3- month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). The interaction will occur during supervised "in-person" sessions and during telephonic conversations over the 3-month period. Subjects from both groups will be reassessed at the end of 3 months in order to determine objective measures of CPAP adherence, sleep-specific HRQOL Functional outcomes of sleep questionnaire [FOSQ]), vigilance (psychomotor vigilance testing), measures of self-efficacy (outcome expectancy, treatment self-efficacy, and risk perception [SEMSA questionnaire]) and patient activation (Patient Activation Measure [PAM]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Peer-driven interventionTrained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). |
| Arm 2 | Active comparator | Other: Usual CareUsual care |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obstructive Sleep Apnea (defined by Apnea-hypopnea index [AHI] > 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography.
- Age range 21 - 85 years old.
- Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months.
- No regular use (> 3 times/week) of sedative or hypnotic medications in the last 4 months.
Key exclusion criteria (12 listed)
- Central sleep apnea (central apnea index > 5 per hour and >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
- Complex sleep apnea or CPAP emergent central apnea (Central apnea index > 5 per hour during CPAP titration with >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
- Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation.
- Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease
- Chronic narcotic use
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 |
|---|---|---|
| Peer-driven interventionAlso: Peer-buddy system (PBS)Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). | Behavioural | Arm 1 |
| Usual CareAll participants will receive usual care following initiation of CPAP therapy. Visits with respiratory therapist and sleep physician wherein patients are educated about the basics of the care and operation of the device, mask and related equipment. Subsequently, their CPAP adherence is monitored and appropriate interventions such as mask change and re-education undertaken as needed. | Other | Arm 2 |
Primary outcome
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Three months
6 secondary outcomes
CPAP adherence
Time frame: Three months
Patient Activation Measure (PAM) survey assessment tool
Time frame: Three months
Self efficacy measure for sleep apnea
Time frame: Three months
Psychomotor vigilance test
Time frame: three months
Patient acceptability of peer-based intervention
Time frame: Three months
Epworth sleepiness score
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Background: PubMed 21731126Parthasarathy S. The need for pharmacovigilance in sleep medicine. Sleep. 2011 Jul 1;34(7):827-8. doi: 10.5665/SLEEP.1096. No abstract available.
- Derived from this study: PubMed 23772186Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.
- http://www.aasmnet.org/jcsm/AcceptedPapers/JC-006-13.pdfLink provided by the sponsor.
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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.
Sairam Parthasarathy, MD principal investigator
Southern Arizona VA Health Care System, Tucson, AZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-driven intervention in people with Sleep Apnea, run by US Department of Veterans Affairs 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 12 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 7 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Outcomes of Sleep Questionnaire (FOSQ) (time frame: Three months). 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 NCT01164683, which also lists 2 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 7 Apr 2015.