Remote Monitoring in Obstructive Sleep Apnea
|ClinicalTrials.gov Identifier: NCT01678560|
Recruitment Status : Terminated (Recruitment was halted due to the difficulties in recruiting.)
First Posted : September 5, 2012
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Monitoring every 3 months by face-to-face visits Device: Frequent remote monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
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|
- Positive airway pressure treatment adherence [ Time Frame: 12 months ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678560
|United States, Connecticut|
|VA Connecticut Health System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Meir Kryger, MD||VA Connecticut Healthcare System|