N/A N=270 Randomized Single-blind Supportive Care

Self-Management of Continuous Positive Airway Pressure Settings

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT03536572 ↗

Enrolled (actual)

270

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Treatment Adherence — 2.1; 2.2 Hours per night

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sleep Apnea Self-Management Program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Adherence	2.1; 2.2	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03536572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.