Phase 3 N=280 Randomized Single-blind Treatment

Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Sleep Apnea Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT00682838 ↗

Enrolled (actual)

280

Serious AEs

0.0%

Results posted

Sep 2016

Primary outcome: Primary: Nightly CPAP Adherence — 3.7; 3.7; 3.7; 3.2 hours per night — p=0.50

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Self-management (Behavioral); Telemonitored care (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Nightly CPAP Adherence	3.7; 3.7; 3.7; 3.2	0.50

Summary

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

Eligibility Criteria

Inclusion criteria were:

Diagnosis of OSA
Prescription for CPAP treatment by a sleep physician
Being CPAP naïve (ie, no previous use of CPAP).

Exclusion criteria were:

Residence in a geographical area outside of San Diego County
Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
Significant documented substance/chemical abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00682838). 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.