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Self-Management of Continuous Positive Airway Pressure Settings

Self-Management of Continuous Positive Airway Pressure Settings for Veterans With Sleep Apnea

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03536572
Acronym
ImPRESS
Enrollment
270
Registered
2018-05-24
Start date
2018-10-01
Completion date
2023-04-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea Syndromes, Chronic Disease, Adherence, Self-Care, Patient Outcomes

Brief 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, 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.

Interventions

Protocol-based sleep apnea and CPAP education and support

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Adherence2 monthsMeasurement of the amount of time that CPAP is used on average per night over the outcome time frame

Countries

United States

Participant flow

Participants by arm

ArmCount
Sleep Apnea Self-Management Program
Protocol-based sleep apnea and CPAP education and support Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
96
Individualized Pressure Adjustment
Additional education and support that will allow them to adjust their PAP pressures Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
113
Total209

Baseline characteristics

CharacteristicSleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants9 Participants15 Participants
Age, Categorical
Between 18 and 65 years
90 Participants104 Participants194 Participants
Age, Continuous46.3 years
STANDARD_DEVIATION 11.8
48.1 years
STANDARD_DEVIATION 12.6
47.27 years
STANDARD_DEVIATION 12.2
Apnea-Hypopnea Index24.5 Events per hour
STANDARD_DEVIATION 21.6
26.3 Events per hour
STANDARD_DEVIATION 23.2
25.5 Events per hour
STANDARD_DEVIATION 22.4
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
14 Participants26 Participants40 Participants
Race (NIH/OMB)
Black or African American
21 Participants15 Participants36 Participants
Race (NIH/OMB)
More than one race
3 Participants2 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants4 Participants6 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants4 Participants
Race (NIH/OMB)
White
54 Participants62 Participants116 Participants
Region of Enrollment
United States
96 participants113 participants209 participants
Sex: Female, Male
Female
13 Participants8 Participants21 Participants
Sex: Female, Male
Male
83 Participants105 Participants188 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 960 / 113
other
Total, other adverse events
0 / 960 / 113
serious
Total, serious adverse events
0 / 960 / 113

Outcome results

Primary

Treatment Adherence

Measurement of the amount of time that CPAP is used on average per night over the outcome time frame

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Sleep Apnea Self-Management ProgramTreatment Adherence2.1 Hours per nightStandard Deviation 1.5
Individualized Pressure AdjustmentTreatment Adherence2.2 Hours per nightStandard Deviation 1.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026