Phase 3
N=240
Effect of Self-Management on Improving Sleep Apnea Outcomes
Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00310310 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: CPAP Adherence — 2.8; 3.9 hours per night — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sleep Apnea Self-Management Program (Behavioral); Usual care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Adherence |
2.3; 3.1 | 0.023 sig |
| PRIMARY CPAP Adherence |
2.3; 3.1 | 0.023 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
8.4; 8.3 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
8.4; 8.3 | — |
Summary
Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of obstructive sleep apnea
- No previous use of CPAP
- Must be a Veteran with residence within San Diego County
Exclusion Criteria
- Home oxygen therapy
- Fatal comorbidities (i.e., life expectancy less than 6 mos)
- Contraindications for CPAP use
Data sourced from ClinicalTrials.gov (NCT00310310). 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.