Sleep Apnea SyndromesPhase 2/3NCT00662623
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
A Phase 2/3 study testing i-PAP in people with Sleep Apnea Syndromes, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used. 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?
- i-PAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2010
- Phase
- Phase 2/3
- 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
- age > 18 years
- confirmed diagnosis of OSA
- being newly prescribed CPAP therapy
- having chronic symptoms as noted on screening symptom checklist
- fluency in English
Who cannot join
- cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
- 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 or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Medical Research Foundation
San Diego, California, 92161
About this study
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.
Read the detailed description
Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- i-PAP, Usual Care (Standard Care)
- Keywords
- Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment
- 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.
i-PAPBehavioural
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Usual Care (Standard Care)Behavioural
Pre-determined clinic visits and telephone support
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: i-PAP |
| 2 | Active comparator | Usual Care (Standard Care) Receives: Behavioral: Usual Care (Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence
Measured: 4 months
Secondary outcomes (1)
Quality of patient-centered collaborative care
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl J. Stepnowsky, Veterans Medical Research Foundation
- Investigators
- Carl J. Stepnowsky, PhD, Principal investigator, Veterans Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662623
- Sponsor's protocol ID
- HS-17246-01
- Status last verified
- May 2016
- First submitted
- 16 Apr 2008
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
- ClinicalTrials.gov ID
- NCT00662623
- Acronym / sponsor ID
- HS-17246-01
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Apr 2008 (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 purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.
Detailed description
Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: i-PAP |
| 2 | Active comparator | Behavioral: Usual Care (Standard Care)Usual Care (Standard Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years
- confirmed diagnosis of OSA
- being newly prescribed CPAP therapy
- having chronic symptoms as noted on screening symptom checklist
- fluency in English
Key exclusion criteria (4 listed)
- cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
- 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 or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
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 |
|---|---|---|
| i-PAPInternet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care | Behavioural | 1 |
| Usual Care (Standard Care)Pre-determined clinic visits and telephone support | Behavioural | 2 |
Primary outcome
CPAP Adherence
Time frame: 4 months
1 secondary outcome
Quality of patient-centered collaborative care
Time frame: 4 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 13 May 2016.
Related trials for Sleep Apnea Syndromes
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
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DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
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
Veterans Medical Research Foundation
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 i-PAP in people with Sleep Apnea Syndromes, run by Veterans Medical Research Foundation 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 5 inclusion and 4 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 13 May 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?
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?
CPAP Adherence (time frame: 4 months). 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 13 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.