CClinicalTrials.gg
CompletedNCT03536572ImPRESSUpdated Sep 19, 2024Results posted

Self-Management of Continuous Positive Airway Pressure Settings

An interventional study of Sleep Apnea Self-Management Program in Obstructive Sleep Apnea, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Sleep Apnea Syndromes
  • Chronic Disease
  • Adherence
  • Self-Care
  • Patient Outcomes
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 270 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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 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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
270 participants (actual)

Study arms

  • Active comparator
    Sleep Apnea Self-Management Program

    Protocol-based sleep apnea and CPAP education and support

    Behavioral: Sleep Apnea Self-Management Program

  • Experimental
    Individualized Pressure Adjustment

    Additional education and support that will allow them to adjust their PAP pressures

    Behavioral: Sleep Apnea Self-Management Program

Interventions

  • BehavioralSleep Apnea Self-Management Program

    Protocol-based sleep apnea and CPAP education and support

    Also known as: SASMP

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneSleep Apnea Self-Management ProgramIndividualized Pressure Adjustment
Started134136
Completed96113
Not completed3823

Outcome measures

PrimaryTreatment Adherence

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

Time frame:
2 months
Reported as:
Mean · Hours per night
Treatment Adherence
Hours per nightSleep Apnea Self-Management ProgramIndividualized Pressure Adjustment
Treatment Adherence2.1 ± 1.52.2 ± 1.6

Adverse events

Collected over 1 month and 2 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sleep Apnea Self-Management Program0/96 (0%)0/96 (0%)0/96 (0%)
Individualized Pressure Adjustment0/113 (0%)0/113 (0%)0/113 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
<=18 years000
Between 18 and 65 years90104194
>=65 years6915
Age, Continuous
Age, Continuous(years)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
Mean46.3 ± 11.848.1 ± 12.647.27 ± 12.2
Sex: Female, Male
Sex: Female, Male(Participants)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
Female13821
Male83105188
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
American Indian or Alaska Native112
Asian142640
Native Hawaiian or Other Pacific Islander246
Black or African American211536
White5462116
More than one race325
Unknown or Not Reported134
Region of Enrollment
Region of Enrollment(participants)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
United States96113209
Apnea-Hypopnea Index
Apnea-Hypopnea Index(Events per hour)Sleep Apnea Self-Management ProgramIndividualized Pressure AdjustmentTotal
Mean24.5 ± 21.626.3 ± 23.225.5 ± 22.4
08

Study locations

1 site
  • VA San Diego Healthcare System, San Diego, CA
    San Diego, California 92161-0002, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03536572
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Oct 1, 2018
Primary completion
Mar 31, 2023
Completion
Apr 30, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Carl J Stepnowsky, Jr., PhD
principal investigator · VA San Diego Healthcare System, San Diego, CA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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