Remote Monitoring in Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by VA Connecticut Healthcare System
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01678560
First received: August 30, 2012
Last updated: December 8, 2014
Last verified: December 2014

August 30, 2012
December 8, 2014
January 2014
June 2016   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01678560 on ClinicalTrials.gov Archive Site
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).
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)
Not Provided
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.
 
Remote Monitoring in Obstructive Sleep Apnea
Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans

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.

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: Monitoring every 3 months by face-to-face visits
  • Device: Frequent remote monitoring
  • 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.
    Intervention: 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.
    Intervention: Device: Frequent remote monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed OSA patients
  • AHI of 5/hour 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
  • Prescribed BiPap or ASV, which are other types of PAP
Both
18 Years to 90 Years
No
Contact: Meir Kryger, MD 203-815-0914
United States
 
NCT01678560
01648
No
VA Connecticut Healthcare System
VA Connecticut Healthcare System
Not Provided
Principal Investigator: Meir Kryger, MD VA Connecticut Healthcare System
VA Connecticut Healthcare System
December 2014

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