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Remote Monitoring in Obstructive Sleep Apnea

NCT01678560 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-12-11

Study results available
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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.

Conditions

Interventions

DEVICE

Monitoring every 3 months by face-to-face visits

These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.

DEVICE

Frequent remote monitoring

These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls

Sponsors & Collaborators

  • VA Connecticut Healthcare System

    lead FED

Principal Investigators

  • Meir Kryger, MD · VA Connecticut Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678560 on ClinicalTrials.gov