Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea Syndromes |
Behavioral: Self-management Behavioral: Telemonitored care |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring |
- Treatment adherence [ Time Frame: 3 mos ] [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | July 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Active Intervention
|
Behavioral: Self-management
Self-management
|
|
Active Comparator: Arm 2
Active Comparator
|
Behavioral: Telemonitored care
Telemonitored care
|
|
Experimental: Arm 3
1+2
|
Behavioral: Self-management
Self-management
Behavioral: Telemonitored care
Telemonitored care
|
|
No Intervention: Arm 4
Usual care
|
Detailed Description:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with obstructive sleep apnea
- Live in San Diego County
- Veteran
Exclusion Criteria:
- Previous use of positive airway therapy
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Carl J. Stepnowsky, PhD | San Diego Veterans Healthcare System |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00682838 History of Changes |
| Other Study ID Numbers: | IIR 07-163, 080139 |
| Study First Received: | May 12, 2008 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Treatment compliance Self-management Telemedicine |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013