Telemedici ne Management of Veterans With Newly Diagnosed Obstructiv e Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Automatically titrating continuous positive airway pressure (APAP) and continuous positive
      airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea.
      There is a growing body of evidence that suggests that early patient education and
      intervention may improve adherence with positive airway pressure. The investigators plan a
      prospective, randomized trial to see if telemonitoring in the first several weeks of PAP
      therapy improves adherence following 3 months of treatment.
    

Detailed description: 
      Obstructive sleep apnea is a high-priority clinical condition for the Veterans Health
      Administration. With approximately 2% of middle-aged women and 4% of middle-aged men having
      OSA, the disorder places significant burden on the healthcare system. Obstructive sleep apnea
      (OSA) has been linked to major cardiovascular disorders such as coronary artery disease,
      congestive heart failure, hypertension, and stroke, as well as increased risk for motor
      vehicle crashes. Positive airway pressure (PAP) therapy is considered the treatment of choice
      for obstructive sleep apnea. However, adherence rates with CPAP and APAP therapy are
      disappointingly low. Veterans, especially those who are socioeconomically disadvantaged and
      those with psychiatric disease, demonstrate poor adherence when compared to the general
      population. Effective interventions are needed to improve adherence among patients diagnosed
      with OSA.

      Currently, veterans diagnosed with OSA at the Philadelphia VA sleep center are treated with a
      home APAP machine that records their adherence on a smart card. They are scheduled for a
      follow-up appointment within one to three months after their initiation of APAP therapy to
      discuss questions and concerns regarding the machine as well as the mask and to download
      their adherence data. Given the limited availability of clinic appointments, some patients
      may have to wait longer than this.

      More recently, APAP machines now distributed through the VA system offer the possibility of
      using wireless transmissions to track adherence data, including hours of use, mask leak, and
      apnea-hypopnea index (this transmission does not require hook up to the telephone and does
      not require the patient to have internet access). This offers the opportunity to see if
      remote monitoring within the first several weeks of APAP treatment improves adherence, and in
      turn, improves clinical response to treatment. At the present time, all patients enrolled at
      Philadelphia Veterans Administration Medical Center (PVAMC) who are newly diagnosed with OSA
      are being provided with APAP machines with modems that allow for wireless transmissions of
      data through the Phillips Respironics HIPPA compliant website, www.encoreanywhere.com. Review
      of the modem data is being performed on a limited basis in some patients. If remote
      monitoring improves adherence, the investigators may want to implement it for all APAP users.
      At present, the investigators do not know if this is a clinically effective or cost effective
      model for delivering health care.

      The investigators will have a baseline chart review. It will include assessment of APAP
      settings (auto-titrate pressure ranges), model and size of mask interface, baseline sleep
      study results (mean AHI), and review of surveys now obtained as part of routine clinical care
      at the investigators sleep center, including: Epworth Sleepiness Scale (ESS) score,
      functional outcomes of sleep questionnaire (FOSQ) score, center for epidemiological studies
      of depression scale (CES-D score), short form health survey (SF-12), a health survey score
      and client satisfaction questionnaire (CSQ-8).

      Sleep center staff will also perform a chart review to obtain demographic information (age,
      sex, race), BMI, daytime oxygen saturation (if available), and co-morbidities (congestive
      heart failure, diabetes, hypertension, obesity, chronic obstructive pulmonary disease (COPD),
      and depression or other psychological disorders) as part of their problem list in the
      computerized VA medical record. the investigators will use this chart review to compute a
      Charlson Morbidity Index.

      The investigators then plan to randomize 126 patients to either usual care or usual care in
      addition to telemonitoring.

      Standard of Care Arm: Patients assigned to receive standard of care will be set-up with an
      APAP machine through Eagle Home Medical, our contracted local home health care agency.
      Patients will also receive the sleep staff's phone number should they encounter problems with
      the use of their new equipment. Patients will be scheduled to see a sleep practitioner within
      one to three months of the initiation of APAP therapy.

      At the follow-up office visit, practitioners will assess mask leak, mean daily APAP usage,
      AHI through either secure digital (SD) cards or Encore Anywhere. Practitioners will also
      calculate the patient's ESS score and inquire about frequent complications associated with
      APAP-usage, such as dry mouth and mask discomfort.

      After three months of treatment, all patients in the usual care arm will also have their
      EncoreAnywhere data reviewed. They will receive a phone call from our sleep center staff to
      assess their experience with their APAP machines. If patients have not had a follow-up clinic
      visit, they will be scheduled for one. In addition, all subjects will be mailed survey to
      reassess their functional outcomes including: ESS score, FOSQ- 10, another subjective
      measurement of sleepiness, the CES-D score, an assessment of depression symptoms, the CSQ-8,
      an assessment of patient satisfaction, and the SF-12 health survey, an assessment of health.

      Telemonitoring Arm: Patients will be set-up with an APAP machine through Eagle Home Medical,
      our contracted local home health care agency. Patients will also receive the sleep staff's
      phone number should they encounter problems with the use of their new equipment. Patients
      will be scheduled to see a sleep practitioner within one to three months of the initiation of
      APAP therapy. At that follow-up appointment, APAP settings, APAP adherence, mask comfort,
      humidifier usage, and ESS score will be assessed.

      In addition, patients in the telemonitoring arm will have their adherence data monitored by
      sleep research staff. Patients who demonstrate poor adherence will receive phone calls at
      scheduled intervals (Day 2, Day 9, and Day 16). Poor adherence is defined as a large mask
      leak for 30% of the night, 30% or more of days with less than 4 hours of use, or an AHI > 10
      events/hr.

      Day 2 (Can call up to 120 hours after initiation of treatment) Two days after initiation of
      APAP data, intervention arm patients will have their data reviewed by the sleep study staff.
      Patients will receive a follow-up call if any of the following are present: large mask leak,
      30% or more of days with less than 4 hours of use, or machine measured average AHI > 10
      events/hr. Patients will be assessed for symptoms such as dry mouth, mask issues, or
      discomfort with the device, or any other problems. Interventions to improve adherence (i.e.:
      a different mask, chin strap, modifications of pressure settings, modifications of humidifier
      settings, saline nasal sprays) will then be prescribed if needed. Patients will also be given
      the sleep center number if they have questions regarding the use of their equipment.

      Day 9: (Can call up to 120 hours after Day 9) Patients in the intervention arm will have
      their data reviewed again. They will receive a follow-up call if poor adherence is noted.
      Symptoms will be assessed and interventions to improve adherence will be offered.

      Day 16: (Can call up to120 hours after Day 16) Patients in the intervention are will have
      their data reviewed again and called if poor adherence and/or efficacy is noted. Symptoms
      will be assessed and interventions to improve adherence will be offered.

      Three Month Follow-up: All patients will have their EncoreAnywhere data reviewed. If patients
      have not had a follow-up visit within one to three months of APAP set-up, they will be
      scheduled for one. Surveys will be mailed to all subjects to reassess functional outcomes,
      including: ESS, FOSQ, CES-D, SF-12 health survey, and CSQ-8.
    

Intervention name(s): Telemonitoring
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; adherence; telemedicine; auto-titrating continuous positive airway pressure