Remote Monitoring in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01678560
• Other study ID #: 01648
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2019
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	VA Connecticut Health System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months	Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.	First 3 months
Primary	Number of Participants With Positive Airway Pressure Treatment Adherence After 3 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	4-12 Months
Secondary	Receiving Effective Treatment for Obstructive Sleep Apnea	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.	12 months