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Phase 3 Completed N=240 Randomized Single-blind Other

Effect of Self-Management on Improving Sleep Apnea Outcomes

Sleep Apnea Syndromes
Source: ClinicalTrials.gov NCT00310310 ↗
Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: CPAP Adherence — 2.8; 3.9 hours per night — p=0.001
◆ Published Evidence
Highly cited
116citations · ~6 / year
Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea.
Journal of medical Internet research · 2007 · Open access · High-confidence link

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.

Linked Publications (4)

  • Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea.
    Journal of medical Internet research · 2007 · 116 citations · Open access · High-confidence link
  • Sleep and Its Disorders in Seniors.
    Sleep medicine clinics · 2008 · 79 citations · Open access · High-confidence link
  • A self-management approach to improving continuous positive airway pressure adherence and outcomes.
    Behavioral sleep medicine · 2007 · 64 citations · High-confidence link
  • CPAP Adherence is Associated With Attentional Improvements in a Group of Primarily Male Patients With Moderate to Severe OSA.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017 · 15 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
CPAP Adherence
2.3; 3.1 0.023 sig
SECONDARY
Pittsburgh Sleep Quality Index (PSQI)
8.4; 8.3

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00310310) and the linked publication. 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. Informational only — not medical advice.

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