Sleep Apnea SyndromesPhase 2/3NCT00682838
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
A Phase 2/3 study testing Self-management and Telemonitored care in people with Sleep Apnea Syndromes, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Self-management and Telemonitored care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2012
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OSA
- Prescription for CPAP treatment by a sleep physician
- Being CPAP naïve (ie, no previous use of CPAP).
Who cannot join
- Residence in a geographical area outside of San Diego County
- Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
- Significant documented substance/chemical abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.
Read the detailed description
The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future.
The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group.
A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group.
And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Self-management, Telemonitored care
- Keywords
- Treatment compliance, Self-management, Telemedicine
- Medical subject headings
- Sleep Apnea Syndromes, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-managementBehavioural
Self-management
Telemonitored careBehavioural
Telemonitored care
| Study group | Role | What they receive |
|---|---|---|
| Self-Management (SM) | Experimental | Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective Receives: Behavioral: Self-management |
| Telemonitored Care (TC) | Active comparator | Active Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol Receives: Behavioral: Telemonitored care |
| SM + TC | Experimental | Self-management and Telemonitored care: Combination of both SM + TC intervention Receives: Behavioral: Self-management; Behavioral: Telemonitored care |
| Usual care (UC) | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightly CPAP Adherence
Nightly CPAP adherence hours per night measured over the three-months period
Measured: 3 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionJun 2012
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.
- Other trials for Sleep Apnea SyndromesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Carl J Stepnowsky, PhD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682838
- Sponsor's protocol ID
- IIR 07-163
- Other IDs
- 080139
- Status last verified
- Jul 2016
- First submitted
- 12 May 2008
- Last updated
- 1 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
- ClinicalTrials.gov ID
- NCT00682838
- Acronym / sponsor ID
- IIR 07-163
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Treatment compliance, Self-management, Telemedicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, San Diego
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 1 Sep 2016
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 major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.
Detailed description
The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future.
The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group.
A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group.
And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-Management (SM) | Experimental | Behavioral: Self-managementActive Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective |
| Telemonitored Care (TC) | Active comparator | Behavioral: Telemonitored careActive Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol |
| SM + TC | Experimental | Behavioral: Self-management, Behavioral: Telemonitored careSelf-management and Telemonitored care: Combination of both SM + TC intervention |
| Usual care (UC) | No intervention | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of OSA
- Prescription for CPAP treatment by a sleep physician
- Being CPAP naïve (ie, no previous use of CPAP).
Key exclusion criteria (3 listed)
- Residence in a geographical area outside of San Diego County
- Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
- Significant documented substance/chemical abuse
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 |
|---|---|---|
| Self-managementSelf-management | Behavioural | SM + TC, Self-Management (SM) |
| Telemonitored careTelemonitored care | Behavioural | SM + TC, Telemonitored Care (TC) |
Primary outcome
Nightly CPAP Adherence
Time frame: 3 mos
Nightly CPAP adherence hours per night measured over the three-months period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Carl J Stepnowsky, PhD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Self-management and Telemonitored care in people with Sleep Apnea Syndromes, 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 3 inclusion and 3 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 1 Sep 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2016). 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?
Nightly CPAP Adherence (time frame: 3 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2016.