Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by VA Connecticut Healthcare System.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01678560
First received: August 30, 2012
Last updated: March 25, 2013
Last verified: September 2012

August 30, 2012
March 25, 2013
April 2013
December 2013   (final data collection date for primary outcome measure)
Postive airway pressure treatment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean PAP use being > 4 hours per night for greater than 70% of nights.
Same as current
Complete list of historical versions of study NCT01678560 on ClinicalTrials.gov Archive Site
PAP treatment efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluate the effect active continuous monitoring among patients with sleep apnea on mean nightly residual respiratory disturbance index (RDI), Epworth Sleepiness Scale, Sleep Apnea Quality of Life Index (SAQLI) and Functional Outcomes Of Sleep Questionnaire. (FOSQ)
Same as current
Treatment costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare total costs to patients (sleep clinic visits, travel time, work days missed) and the VA system (travel by homecare providers, sleep clinic visits, supplies) of delivery of OSA management at 30 days, 90 days, 180 days and 1 year between patients receiving conventional CPAP management or active continuous wireless monitoring.
Same as current
 
Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study
Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study

Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment, and markedly reduce cost to the VA system. The investigators will compare two technologies; storing the data on secure digital cards to follow the patient versus using secure wireless technology to gather the data, a cloud system to store the data, and staff that would be notified in the event of anomalies in treatment use or effectiveness.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Obstructive Sleep Apnea
  • Device: Secure digital (SD) card monitoring
  • Device: Wireless monitoring
  • Active Comparator: Secure digital (SD) card Monitoring
    These patients will be monitored using secure digital (SD) cards as the method to obtain adherence and efficacy data.
    Intervention: Device: Secure digital (SD) card monitoring
  • Experimental: Wireless management
    These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
    Intervention: Device: Wireless monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
220
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed OSA patients
  • RDI 15 or greater
  • Prescribed CPAP therapy
  • Able to comply with treatment and understand treatment instructions

Exclusion Criteria:

  • Not able to understand study requirements
  • Significant cardiorespiratory disease (e.g. COPD, severe CHF)
  • Clinical instability at time of apnea diagnosis
Both
18 Years to 80 Years
No
United States
 
NCT01678560
01648
No
VA Connecticut Healthcare System
VA Connecticut Healthcare System
Not Provided
Principal Investigator: Meir Kryger, MD VA Connecticut Healthcare System
Principal Investigator: Carl Stepnowsky, PhD San Diego Veterans Healthcare System
VA Connecticut Healthcare System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP