Remote Monitoring in Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
VA Connecticut Healthcare System

Brief Summary:
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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Positive airway pressure treatment adherence [ Time Frame: 12 months ]
    Mean PAP use being > 4 hours per night for greater than 70% of nights.

Secondary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01678560

United States, Connecticut
VA Connecticut Health System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Principal Investigator: Meir Kryger, MD VA Connecticut Healthcare System

Responsible Party: VA Connecticut Healthcare System Identifier: NCT01678560     History of Changes
Other Study ID Numbers: 01648
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016

Keywords provided by VA Connecticut Healthcare System:
Obstructive sleep apnea PAP adherence efficacy economics

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases