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Obstructive Sleep ApneaNCT01678560

Remote Monitoring in Obstructive Sleep Apnea

A study testing Monitoring every 3 months by face-to-face visits and Frequent remote monitoring in people with Obstructive Sleep Apnea, run by VA Connecticut Healthcare System at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Monitoring every 3 months by face-to-face visits and Frequent remote monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Jan 2014to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed OSA patients
  • AHI of 5/hour or greater
  • Prescribed CPAP therapy
  • Able to comply with treatment and understand treatment instructions

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Connecticut Health System

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans

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.

Read the 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.

Being tested
Monitoring every 3 months by face-to-face visits, Frequent remote monitoring
Keywords
Obstructive sleep apnea PAP adherence efficacy economics
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring every 3 months by face-to-face visitsDevice

    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 monitoringDevice

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

Study groups in NCT01678560
Study groupRoleWhat they receive
Usual CareActive comparatorMonitoring 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.
Receives: Device: Monitoring every 3 months by face-to-face visits
Wireless CareActive comparatorFrequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
Receives: Device: Frequent remote monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First 3 months

  2. 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

    Measured: 4-12 Months

Secondary outcomes (1)
  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2012 (estimated)
  2. Study startJan 2014
  3. Primary completionNov 2016
  4. Study completionDec 2016

Why it stopped: Recruitment was halted due to the difficulties in recruiting.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678560
Sponsor's protocol ID
01648
Status last verified
Dec 2019
First submitted
30 Aug 2012
Last updated
11 Dec 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 30736874

Questions about this trial

What is this clinical trial studying?

A study testing Monitoring every 3 months by face-to-face visits and Frequent remote monitoring in people with Obstructive Sleep Apnea, run by VA Connecticut Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months (time frame: First 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01678560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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