Remote Monitoring in Obstructive Sleep Apnea

• ClinicalTrials.gov Identifier: NCT01678560
• Recruitment Status: Terminated
• First Posted: September 5, 2012
• Results First Posted: December 11, 2019
• Last Update Posted: December 11, 2019
• Sponsor: VA Connecticut Healthcare System
• Information provided by (Responsible Party): VA Connecticut Healthcare System

Study Description

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

Detailed Description:

Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA) Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or unattended home sleep testing was performed at the evaluating clinician's discretion. Clinicians that saw the patient determined whether PAP therapy was needed, and either auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were ordered for the patient. Patients received education about OSA and about their equipment from a respiratory therapist and physician's assistant within the VA who then provided the equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider were screened for participation in the study.The study was overseen by the Institutional Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut. Informed consent was obtained from all participants.

Patients were included in the study if they were diagnosed with OSA (defined as AHI or apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour), and if they were being exposed to PAP for the first time. Patients who were previously treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital admissions (=< 2 weeks), or were living outside cellular network coverage area were excluded from the study.

Patients that met study inclusion criteria were provided ResMed S9 devices with wireless modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based system for the ResMed devices. After the initial setup and educational settings, the patients received supplies as needed and troubleshooting of side effects of treatment as needed. Devices were not removed after 3 months if they were not adherent.

Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed by the clinician at these intervals.

Patients in the wireless care group were monitored more frequently using wireless modems as the method to obtain adherence and efficacy data.

We then determined adherence using CMS (Centers for Medicare & Medicaid Services) criteria at 3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were used for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use, and then a consecutive 30-day period in months 4-12. We also examined the daily use from the first to last day looking of overall patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and maintained in a REDCap database (REDCap is a secure web application for building and managing online surveys and databases). Sensitivity and specificity calculations were then performed to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact test was also used to evaluate the association between adherence at 3 months and 1 year and the association between AHI (Apnea -Hypopnea Index) and adherence.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care; 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: 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.
Active Comparator: Wireless Care; Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.	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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months [ Time Frame: First 3 months ]
   Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.
2. Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months [ Time Frame: 4-12 Months ]
   Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as 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 (obstructive sleep apnea) at the end of 12 months.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)
• Clinical instability at time of apnea diagnosis
• Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP

Contacts and Locations

Locations

United States, Connecticut

VA Connecticut Health System

West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

VA Connecticut Healthcare System

Investigators

• Principal Investigator: Meir Kryger, MD; VA Connecticut Healthcare System

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naik S, Al-Halawani M, Kreinin I, Kryger M. Centers for Medicare and Medicaid Services Positive Airway Pressure Adherence Criteria May Limit Treatment to Many Medicare Beneficiaries. J Clin Sleep Med. 2019 Feb 15;15(2):245-251. doi: 10.5664/jcsm.7626.

• Responsible Party: VA Connecticut Healthcare System
• ClinicalTrials.gov Identifier: NCT01678560
• Other Study ID Numbers: 01648
• First Posted: September 5, 2012
• Results First Posted: December 11, 2019
• Last Update Posted: December 11, 2019
• Last Verified: December 2019

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; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases