Remote Monitoring in Obstructive Sleep Apnea
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. The investigators will compare two methods. Usual care involves downloading data from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit. Wireless care involved more frequent monitoring and intervention in the event of anomalies in treatment use or effectiveness.
Obstructive Sleep Apnea
Device: Monitoring every 3 months by face-to-face visits
Device: Frequent remote monitoring
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans|
- Positive 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.
- Receiving effective treatment for obstructive sleep apnea [ Time Frame: 12 months ] [ Designated as safety issue: No ]Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA at the end of 12 months. We will also assess whether the residual number of respiratory events on treatment (residual AHI), regardless of modality used for treatment, is satisfactory, and whether subjective measures of sleepiness (Epworth Sleepiness Scale) and quality of life (Calgary Sleep Apnea Quality of Life Index).
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Usual Care
These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.
|Device: Monitoring every 3 months by face-to-face visits|
Active Comparator: Wireless Care
These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
|Device: Frequent remote monitoring|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678560
|Contact: Meir Kryger, MD||203-815-0914|
|United States, Connecticut|
|VA Connecticut Health System||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Meir Kryger, MD email@example.com|
|Contact: Klar Yaggi, MD firstname.lastname@example.org|
|Principal Investigator: Meir Kryger, MD|
|Principal Investigator:||Meir Kryger, MD||VA Connecticut Healthcare System|