Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
2 other identifiers
interventional
280
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
September 1, 2016
CompletedSeptember 1, 2016
July 1, 2016
2.8 years
May 12, 2008
July 8, 2015
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nightly CPAP Adherence
Nightly CPAP adherence hours per night measured over the three-months period
3 mos
Study Arms (4)
Self-Management (SM)
EXPERIMENTALActive Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
Telemonitored Care (TC)
ACTIVE COMPARATORActive Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol
SM + TC
EXPERIMENTALSelf-management and Telemonitored care: Combination of both SM + TC intervention
Usual care (UC)
NO INTERVENTIONControl Group
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of OSA
- Prescription for CPAP treatment by a sleep physician
- Being CPAP naïve (ie, no previous use of CPAP).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System
San Diego, California, 92161, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl J. Stepnowsky, PhD
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Carl J Stepnowsky, PhD
San Diego Veterans Healthcare System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 22, 2008
Study Start
July 1, 2009
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
September 1, 2016
Results First Posted
September 1, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share