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.
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
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.
- Conditions
- Obstructive Sleep Apnea
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Device: Monitoring every 3 months by face-to-face visits |
| Wireless Care | Active comparator | Frequent 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.
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
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)
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.
- First posted5 Sep 2012 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionDec 2016
Why it stopped: Recruitment was halted due to the difficulties in recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Meir Kryger, MD, Principal investigator, VA Connecticut Healthcare System
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans
- ClinicalTrials.gov ID
- NCT01678560
- Acronym / sponsor ID
- 01648
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea PAP adherence efficacy economics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was halted due to the difficulties in recruiting.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Device: Monitoring every 3 months by face-to-face visitsMonitoring 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. |
| Wireless Care | Active comparator | Device: Frequent remote monitoringFrequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed OSA patients
- AHI of 5/hour or greater
- Prescribed CPAP therapy
- Able to comply with treatment and understand treatment instructions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring every 3 months by face-to-face visitsThese 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 | Usual Care |
| Frequent remote monitoringThese patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls | Device | Wireless Care |
Primary outcome
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.
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
1 secondary outcome
Receiving Effective Treatment for Obstructive Sleep Apnea
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30736874Naik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Kryger, MD principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
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.