Obstructive Sleep ApneaEarly Phase 1NCT01335854
Promoting Continuous Positive Airway Pressure (CPAP) Adherence
A Early Phase 1 study testing Web-based Access to CPAP Data and Web-based Access to CPAP Data with Financial Incentive in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Web-based Access to CPAP Data and Web-based Access to CPAP Data with Financial Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Aug 2013
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- Apnea-hypopnea index (AHI) ≥ 10 events/hr on full-night in-laboratory polysomnogram (PSG) based on American Academic of Sleep Medicine (AASM) recommended scoring criteria
- Stable medical history and no change in medications, including anti-hypertensive, thyroid-related, and lipid-lowering medications, in the previous 2 months.
- Access to a telephone and the internet on all days of the week
- No regular use (> 3 times/week) of sedative or hypnotic medications in the last 2 months
Who cannot join
- Unable or unwilling to provide informed consent
- Are enrolled in other, ongoing clinical trials
- Inability to return for follow-up testing
- Previous diagnosis of another sleep disorder other than obstructive sleep apnea (OSA) (e.g., periodic limb movement disorder [≥ 15 limb movements/hr of sleep with arousal], central sleep apnea [≥ 50% of apneas on diagnostic PSG are central apneas], obesity hypoventilation syndrome, narcolepsy, or night eating syndrome
- Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other non-nasal surgery for OSA
- Requiring oxygen or bilevel positive airway pressure for treatment of OSA
Show all 11Show fewer
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
- Systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg following 10 minutes at rest
- Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
- Unable to perform tests due to inability to communicate verbally, inability to read and write; 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)
- Inability to use CPAP due to claustrophobia, facial pathology, etc.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: Promoting CPAP Adherence and Treatment Outcomes in Patients With Obstructive Sleep Apnea
The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care.
The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.
Read the detailed description
This is a nested clinical study in the NIH funded research project RC2AG036592, "Developing Interactive Technology to Improve Research and Health Behavior". The purpose of the research project is to create a web-based infrastructure to accelerate research in behavioral economics to improve health. Failure to adhere to medical treatments is a major cause of poor outcomes that increase health care spending. Changing unhealthful behaviors is difficult. One barrier to behavioral change is the need to provide patients with immediate, timely information about their behavior. Individual clinicians cannot maintain the frequent contact that is required, but technology and automated feedback mechanisms can keep these issues salient for patients. Internet technology is increasingly seen as an appealing tool to overcome this barrier and promote patient self-management. Recent evidence indicates that providing patients with web-based feedback of their health status may improve adherence to treatment and outcomes.
Another barrier to behavioral change is that people need frequent reinforcement of positive behavior and need that reinforcement often at the time they are making decisions (e.g., to smoke, to overeat, to take medication). Recent studies report that the use of financial incentives is an effective strategy to changing health behavior. Incentives in the form of direct payments provide valuable positive reinforcement and have been shown to change health behavior in a variety of contexts, including weight loss, medication adherence, and smoking cessation. One criticism of this approach to changing health behaviors is whether the new behavior is sustained once the financial incentive is withdrawn.
The proposed clinical study will use the web-based infrastructure that is developed by the research project to evaluate the application of these emerging new approaches in behavioral health intervention to improving CPAP adherence and consequent treatment outcomes in patients with OSA. In the proposed research study, 120 patients with newly diagnosed OSA who are being initiated on CPAP therapy will be randomized to one of three arms: 1) usual care, 2) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website, and 3) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website combined with a daily financial incentive in the first week based of hours per day of CPAP use. The proposed health behavior interventions will 1) provide patients greater access to information about their sleep disordered breathing, and 2) allow patients to become active members of their management team. Aim 1 will determine if the proposed health behavior interventions improve average daily hours of CPAP use in the first week and following 3 months of treatment. The overall hypothesis is that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.
Interventions designed to improve health-related behavior will only be justified if they lead to greater improvements in clinically relevant outcomes. To determine the impact of the proposed health behavior interventions to increase CPAP adherence on treatment outcomes, Aim 2 will compare measures of daytime function following 3 months of CPAP treatment across the three groups. The results of Aim 2 will demonstrate whether improvements in CPAP adherence due to web-based feedback with or without a financial incentive result in greater improvements in clinical outcomes.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Web-based Access to CPAP Data, Web-based Access to CPAP Data with Financial Incentive
- Keywords
- Apnea-hypopnea index, Continuous positive airway pressure, CPAP adherence
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Access to CPAP DataBehavioural
Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the study, and then as frequently as they choose after the first week.
Web-based Access to CPAP Data with Financial IncentiveBehavioural
Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the the study, and then as frequently as they choose after the first week. There will be a payment of $30 during the first week for each day a participant uses CPAP for more than 4 hours the previous night and logs on to the website.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care for 3 months. This consists of a phone call after one week of treatment, and clinic appointments at the sleep center following one month and three months of CPAP treatment. |
| Web-Access to CPAP Data | Experimental | Usual care and web-based access to CPAP adherence data for 3 months. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. Receives: Behavioral: Web-based Access to CPAP Data |
| Web-Access to CPAP Data & Incentive | Experimental | Usual care and web-based access to CPAP data for 3 months with financial incentives. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. Financial incentive terminated after 1 week. Receives: Behavioral: Web-based Access to CPAP Data with Financial Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily hours of CPAP.
Average daily hours of CPAP use determined objectively by the mask-on time recorded by the CPAP machine.
Measured: 3 months
The change in the mean total score on the Functional Outcome of Sleep Questionnaire.
The change in the mean total score on the Functional Outcome of Sleep Questionnaire (FOSQ-10), a validated, disease specific quality of life questionnaire.
Measured: 3 months
Secondary outcomes (2)
The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.
The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.
Measured: 3 months
Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).
Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Samuel T Kuna, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335854
- Sponsor's protocol ID
- 812091
- Other IDs
- RC2AG036592
- Status last verified
- Mar 2012
- First submitted
- 13 Apr 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.
PubMed 19213683Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
PubMed 19066383Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PubMed 19102784
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting CPAP Adherence and Treatment Outcomes in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01335854
- Acronym / sponsor ID
- 812091
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Apnea-hypopnea index, Continuous positive airway pressure, CPAP adherence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Apr 2011 (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.
The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care.
The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.
Detailed description
This is a nested clinical study in the NIH funded research project RC2AG036592, "Developing Interactive Technology to Improve Research and Health Behavior". The purpose of the research project is to create a web-based infrastructure to accelerate research in behavioral economics to improve health. Failure to adhere to medical treatments is a major cause of poor outcomes that increase health care spending. Changing unhealthful behaviors is difficult. One barrier to behavioral change is the need to provide patients with immediate, timely information about their behavior. Individual clinicians cannot maintain the frequent contact that is required, but technology and automated feedback mechanisms can keep these issues salient for patients. Internet technology is increasingly seen as an appealing tool to overcome this barrier and promote patient self-management. Recent evidence indicates that providing patients with web-based feedback of their health status may improve adherence to treatment and outcomes.
Another barrier to behavioral change is that people need frequent reinforcement of positive behavior and need that reinforcement often at the time they are making decisions (e.g., to smoke, to overeat, to take medication). Recent studies report that the use of financial incentives is an effective strategy to changing health behavior. Incentives in the form of direct payments provide valuable positive reinforcement and have been shown to change health behavior in a variety of contexts, including weight loss, medication adherence, and smoking cessation. One criticism of this approach to changing health behaviors is whether the new behavior is sustained once the financial incentive is withdrawn.
The proposed clinical study will use the web-based infrastructure that is developed by the research project to evaluate the application of these emerging new approaches in behavioral health intervention to improving CPAP adherence and consequent treatment outcomes in patients with OSA. In the proposed research study, 120 patients with newly diagnosed OSA who are being initiated on CPAP therapy will be randomized to one of three arms: 1) usual care, 2) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website, and 3) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website combined with a daily financial incentive in the first week based of hours per day of CPAP use. The proposed health behavior interventions will 1) provide patients greater access to information about their sleep disordered breathing, and 2) allow patients to become active members of their management team. Aim 1 will determine if the proposed health behavior interventions improve average daily hours of CPAP use in the first week and following 3 months of treatment. The overall hypothesis is that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.
Interventions designed to improve health-related behavior will only be justified if they lead to greater improvements in clinically relevant outcomes. To determine the impact of the proposed health behavior interventions to increase CPAP adherence on treatment outcomes, Aim 2 will compare measures of daytime function following 3 months of CPAP treatment across the three groups. The results of Aim 2 will demonstrate whether improvements in CPAP adherence due to web-based feedback with or without a financial incentive result in greater improvements in clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care for 3 months. This consists of a phone call after one week of treatment, and clinic appointments at the sleep center following one month and three months of CPAP treatment. |
| Web-Access to CPAP Data | Experimental | Behavioral: Web-based Access to CPAP DataUsual care and web-based access to CPAP adherence data for 3 months. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. |
| Web-Access to CPAP Data & Incentive | Experimental | Behavioral: Web-based Access to CPAP Data with Financial IncentiveUsual care and web-based access to CPAP data for 3 months with financial incentives. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. Financial incentive terminated after 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age or older
- Apnea-hypopnea index (AHI) ≥ 10 events/hr on full-night in-laboratory polysomnogram (PSG) based on American Academic of Sleep Medicine (AASM) recommended scoring criteria
- Stable medical history and no change in medications, including anti-hypertensive, thyroid-related, and lipid-lowering medications, in the previous 2 months.
- Access to a telephone and the internet on all days of the week
- No regular use (> 3 times/week) of sedative or hypnotic medications in the last 2 months
Key exclusion criteria (11 listed)
- Unable or unwilling to provide informed consent
- Are enrolled in other, ongoing clinical trials
- Inability to return for follow-up testing
- Previous diagnosis of another sleep disorder other than obstructive sleep apnea (OSA) (e.g., periodic limb movement disorder [≥ 15 limb movements/hr of sleep with arousal], central sleep apnea [≥ 50% of apneas on diagnostic PSG are central apneas], obesity hypoventilation syndrome, narcolepsy, or night eating syndrome
- Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other non-nasal surgery for OSA
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 |
|---|---|---|
| Web-based Access to CPAP DataParticipants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the study, and then as frequently as they choose after the first week. | Behavioural | Web-Access to CPAP Data |
| Web-based Access to CPAP Data with Financial IncentiveParticipants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the the study, and then as frequently as they choose after the first week. There will be a payment of $30 during the first week for each day a participant uses CPAP for more than 4 hours the previous night and logs on to the website. | Behavioural | Web-Access to CPAP Data & Incentive |
Primary outcome
Average daily hours of CPAP.
Time frame: 3 months
Average daily hours of CPAP use determined objectively by the mask-on time recorded by the CPAP machine.
The change in the mean total score on the Functional Outcome of Sleep Questionnaire.
Time frame: 3 months
The change in the mean total score on the Functional Outcome of Sleep Questionnaire (FOSQ-10), a validated, disease specific quality of life questionnaire.
2 secondary outcomes
The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.
Time frame: 3 months
Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).
Time frame: 3 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 22 May 2014.
- Background: PubMed 19213683Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.
- Background: PubMed 19066383Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
- Background: PubMed 19102784Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
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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.
Samuel T Kuna, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Web-based Access to CPAP Data and Web-based Access to CPAP Data with Financial Incentive in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 2 sites 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 5 inclusion and 11 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Average daily hours of CPAP. (time frame: 3 months). 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 NCT01335854, which also lists 3 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 22 May 2014.