Obstructive Sleep ApneaImPRESSNCT03536572
Self-Management of Continuous Positive Airway Pressure Settings
A study testing Sleep Apnea Self-Management Program in people with Obstructive Sleep Apnea, 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 millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions, including OSA… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep Apnea Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Apr 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigators' intent is to recruit a study population that is representative of patients diagnosed with OSA. To this end, entry criteria are as inclusive as possible and operationalized as follows:
- confirmed diagnosis of OSA
- being newly prescribed an OSA therapy
- having chronic symptoms per screening symptom checklist
- fluency in English
- receiving medical care at VA San Diego Healthcare System
- OSA diagnosis by the investigators' Pulmonary Sleep Program has been and is currently consistent with published consensus statements50 that therapy is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) >30 or (2) 5-30 AND accompanied by documented OSA symptoms, including EDS, impaired cognition, mood disorders, insomnia, or documented cardiovascular diseases. Because sleep apnea is of increasing importance in women, the investigators' plan is to oversample women by 50% so that they represent 15% of the final study sample.
Who cannot join
- Criteria for exclusion include:
- cognitive impairment sufficient to cause inability to complete the protocol (e.g., documented MMSE < 24/30)
- low health literacy
- residence in a geographical area outside of San Diego County (which could make some necessary in-person visits difficult)
- fatal comorbidity (life expectancy <6 months as indicated by treating physician)
- significant documented substance/chemical abuse
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- other participant circumstances or characteristics that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment (i.e.,:)
- clinical needs of patient outweighs needs of research study
- No exclusion criteria or any other study design elements will be used directly or indirectly to restrict study participation by women or members of minority groups. Some minority groups are thought to have higher OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at the same rates as Caucasians, the investigators expect minority groups to be included in the study at levels equal to or higher than the VA San Diego minority composition.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Self-Management of Continuous Positive Airway Pressure Settings for Veterans With Sleep Apnea
Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions, including OSA, live healthier and more productive lives through better management of their conditions. Adherence with continuous positive airway pressure (PAP) therapy is disappointingly low, and new methods to increase both the use and efficacy of therapy are needed. Historically, patients have not been formally instructed to adjust their pressure settings on their PAP devices; practically, however, allowing patients to adjust their pressure settings fosters engagement, self-confidence, and control with therapy.
Read the detailed description
Because of clinical demands, patients are often under-educated and under-supported about the features of their positive airway pressure (PAP) devices. The most engaged patients are ones who understand the details of their device and change the feature settings so that they can maximize the benefits of therapy. Features settings include humidification level, expiratory pressure relief, pressure ramping, mask alert, auto pressure start, among other important comfort features. Historically, patients have not been provided with access to alter or modify therapy pressure settings, which requires physician prescription. Allied medical staff can carry out subsequent pressure setting changes. It is clear that it is difficult for the healthcare system to engage in optimal chronic disease management, and accommodate the needs of sleep apnea patients early in the treatment initialization process, which requires multiple visits/contacts to ensure that patients are maximizing the use of therapy.
The overarching aim of the proposed project is to examine the effect of providing patients with the ability to adjust their PAP pressure levels on therapy adherence and outcomes. To answer these research questions, the proposed randomized, controlled two-group trial of Sleep Apnea Self-Management Program (SM) and SM plus Individualized Pressure Adjustment (IPA) has the following specific aims related to APAP adherence and efficacy, patient-reported outcomes, and utilization: (1) To examine the effect of Individualized Pressure Adjustment (IPA) of settings on treatment adherence and efficacy (i.e., mask leak and residual apnea-hypopnea index); (2) To examine the effect of SM+IPA versus SM on patient self-reported treatment outcomes; and (3) To describe the effects of SM-IPA and SM groups on utilization.
Sleep apnea is one of the most common chronic conditions in the VA. Positive airway pressure (PAP) therapy is the gold-standard therapy for sleep apnea, but adherence with PAP is suboptimal. VA sleep programs are understaffed relative to clinical demand for education and support. While adaption to PAP therapy has traditionally been achieved through sequential visits and pressure changes initiated by providers during office-based care, self-monitoring and individualized pressure adjustment is an important strategy that would empower Veterans to achieve better control of their OSA. The key impacts of this project are significant for both patients (improved outcomes) and the VA (improved staff efficiencies).
While patients have control over a wide range of comfort features on their PAP devices, historically they have not been formally educated and supported to adjust pressure settings. The unique aspect of this study is the focus on individualizing pressure settings to allow for the maximizing therapeutic benefit, including increased PAP adherence. Importantly, this is done within the context of provider oversight.
The proposed study is a 6-month randomized, controlled, non-blinded, single-center study comparing the Sleep Apnea Self-Management Program (SM) to SM plus Individualized Pressure Adjustment (IPA). Both groups will receive the SM protocol to ensure that they receive identical OSA and PAP education and support. Participants in the intervention arm will be provided with additional education and support that will allow them to adjust their PAP pressures.
Positive findings from this study will result in a Toolkit that can be distributed to provide patients and providers with the knowledge necessary to improve the clinical management of OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep Apnea Self-Management Program
- Keywords
- Sleep Apnea Syndromes, Chronic Disease, Adherence, Self-Care, Patient Outcomes
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Apnea Self-Management ProgramBehavioural
Also called SASMP
Protocol-based sleep apnea and CPAP education and support
| Study group | Role | What they receive |
|---|---|---|
| Sleep Apnea Self-Management Program | Active comparator | Protocol-based sleep apnea and CPAP education and support Receives: Behavioral: Sleep Apnea Self-Management Program |
| Individualized Pressure Adjustment | Experimental | Additional education and support that will allow them to adjust their PAP pressures Receives: Behavioral: Sleep Apnea Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Measurement of the amount of time that CPAP is used on average per night over the outcome time frame
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Oct 2018
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
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 Obstructive 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carl J Stepnowsky, Jr., PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536572
- Sponsor's protocol ID
- IIR 16-277
- Acronym
- ImPRESS
- Status last verified
- Aug 2024
- First submitted
- 14 May 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Continuous Positive Airway Pressure Settings for Veterans With Sleep Apnea
- ClinicalTrials.gov ID
- NCT03536572
- Acronym / sponsor ID
- ImPRESS / IIR 16-277
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea Syndromes, Chronic Disease, Adherence, Self-Care, Patient Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 19 Sep 2024
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 millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions, including OSA, live healthier and more productive lives through better management of their conditions. Adherence with continuous positive airway pressure (PAP) therapy is disappointingly low, and new methods to increase both the use and efficacy of therapy are needed. Historically, patients have not been formally instructed to adjust their pressure settings on their PAP devices; practically, however, allowing patients to adjust their pressure settings fosters engagement, self-confidence, and control with therapy.
Detailed description
Because of clinical demands, patients are often under-educated and under-supported about the features of their positive airway pressure (PAP) devices. The most engaged patients are ones who understand the details of their device and change the feature settings so that they can maximize the benefits of therapy. Features settings include humidification level, expiratory pressure relief, pressure ramping, mask alert, auto pressure start, among other important comfort features. Historically, patients have not been provided with access to alter or modify therapy pressure settings, which requires physician prescription. Allied medical staff can carry out subsequent pressure setting changes. It is clear that it is difficult for the healthcare system to engage in optimal chronic disease management, and accommodate the needs of sleep apnea patients early in the treatment initialization process, which requires multiple visits/contacts to ensure that patients are maximizing the use of therapy.
The overarching aim of the proposed project is to examine the effect of providing patients with the ability to adjust their PAP pressure levels on therapy adherence and outcomes. To answer these research questions, the proposed randomized, controlled two-group trial of Sleep Apnea Self-Management Program (SM) and SM plus Individualized Pressure Adjustment (IPA) has the following specific aims related to APAP adherence and efficacy, patient-reported outcomes, and utilization: (1) To examine the effect of Individualized Pressure Adjustment (IPA) of settings on treatment adherence and efficacy (i.e., mask leak and residual apnea-hypopnea index); (2) To examine the effect of SM+IPA versus SM on patient self-reported treatment outcomes; and (3) To describe the effects of SM-IPA and SM groups on utilization.
Sleep apnea is one of the most common chronic conditions in the VA. Positive airway pressure (PAP) therapy is the gold-standard therapy for sleep apnea, but adherence with PAP is suboptimal. VA sleep programs are understaffed relative to clinical demand for education and support. While adaption to PAP therapy has traditionally been achieved through sequential visits and pressure changes initiated by providers during office-based care, self-monitoring and individualized pressure adjustment is an important strategy that would empower Veterans to achieve better control of their OSA. The key impacts of this project are significant for both patients (improved outcomes) and the VA (improved staff efficiencies).
While patients have control over a wide range of comfort features on their PAP devices, historically they have not been formally educated and supported to adjust pressure settings. The unique aspect of this study is the focus on individualizing pressure settings to allow for the maximizing therapeutic benefit, including increased PAP adherence. Importantly, this is done within the context of provider oversight.
The proposed study is a 6-month randomized, controlled, non-blinded, single-center study comparing the Sleep Apnea Self-Management Program (SM) to SM plus Individualized Pressure Adjustment (IPA). Both groups will receive the SM protocol to ensure that they receive identical OSA and PAP education and support. Participants in the intervention arm will be provided with additional education and support that will allow them to adjust their PAP pressures.
Positive findings from this study will result in a Toolkit that can be distributed to provide patients and providers with the knowledge necessary to improve the clinical management of OSA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea Self-Management Program | Active comparator | Behavioral: Sleep Apnea Self-Management ProgramProtocol-based sleep apnea and CPAP education and support |
| Individualized Pressure Adjustment | Experimental | Behavioral: Sleep Apnea Self-Management ProgramAdditional education and support that will allow them to adjust their PAP pressures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The investigators' intent is to recruit a study population that is representative of patients diagnosed with OSA. To this end, entry criteria are as inclusive as possible and operationalized as follows:
- confirmed diagnosis of OSA
- being newly prescribed an OSA therapy
- having chronic symptoms per screening symptom checklist
- fluency in English
Key exclusion criteria (9 listed)
- cognitive impairment sufficient to cause inability to complete the protocol (e.g., documented MMSE < 24/30)
- low health literacy
- residence in a geographical area outside of San Diego County (which could make some necessary in-person visits difficult)
- fatal comorbidity (life expectancy <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 |
|---|---|---|
| Sleep Apnea Self-Management ProgramAlso: SASMPProtocol-based sleep apnea and CPAP education and support | Behavioural | Individualized Pressure Adjustment, Sleep Apnea Self-Management Program |
Primary outcome
Treatment Adherence
Time frame: 2 months
Measurement of the amount of time that CPAP is used on average per night over the outcome time frame
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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, Jr., PhD principal investigator
VA San Diego Healthcare System, San Diego, 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 Sleep Apnea Self-Management Program in people with Obstructive 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 7 inclusion and 9 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 19 Sep 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 19 Sep 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?
Treatment Adherence (time frame: 2 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 19 Sep 2024.