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
  Purpose

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 Intervention
Obstructive Sleep Apnea
Device: Monitoring every 3 months by face-to-face visits
Device: Frequent remote monitoring

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 220
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678560

Contacts
Contact: Meir Kryger, MD 203-815-0914

Locations
United States, Connecticut
VA Connecticut Health System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Meir Kryger, MD       meir.kryger@yale.edu   
Contact: Klar Yaggi, MD       henry.yaggi@yale.edu   
Principal Investigator: Meir Kryger, MD         
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Meir Kryger, MD VA Connecticut Healthcare System
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01678560     History of Changes
Other Study ID Numbers: 01648
Study First Received: August 30, 2012
Last Updated: December 8, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 30, 2015