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Remote Monitoring in Obstructive Sleep Apnea

10 december 2019 bijgewerkt door: VA Connecticut Healthcare System

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

52

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Connecticut
      • West Haven, Connecticut, Verenigde Staten, 06516
        • VA Connecticut Health System

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
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.
Actieve vergelijker: Wireless Care
Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
Tijdsspanne: 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
Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
Tijdsspanne: 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
4-12 Months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Receiving Effective Treatment for Obstructive Sleep Apnea
Tijdsspanne: 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.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Meir Kryger, MD, VA Connecticut Healthcare System

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2014

Primaire voltooiing (Werkelijk)

1 november 2016

Studie voltooiing (Werkelijk)

1 december 2016

Studieregistratiedata

Eerst ingediend

30 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2012

Eerst geplaatst (Schatting)

5 september 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 december 2019

Laatste update ingediend die voldeed aan QC-criteria

10 december 2019

Laatst geverifieerd

1 december 2019

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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