Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this randomized prospective study is to compare the efficacy of two approaches
      to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having
      obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway
      involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended
      sleep study) followed by CPAP treatment. The other pathway involves treatment with
      auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP
      adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time
      (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep
      Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two
      study arms.
    

Detailed description: 
      RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep
      Education and Evaluation Class before having a sleep study. At this class they receive
      information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete
      a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical
      conditions. Screening of the sleep questionnaire and the patient's medical record is part of
      routine care to identify patients needing a diagnostic PSG and/or an attended titration. At
      the end of the class, participation in the current study will be offered the patients. Those
      signifying interest in being part of the research study and meeting inclusion and exclusion
      criteria will be contacted to participate in the study. Once they sign an informed consent
      they will be randomized to one of the two clinical pathways.

      METHODS: Study visits:

      Before informed consent (routine clinical care)

        1. Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA
           treatment). Patients complete screening sleep and medical history questionnaires.

        2. Determination of patient interest in participating in the current study and review of
           inclusion/exclusion criteria

      After informed consent

        1. PM study

        2. Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the
           patient will be offered a diagnostic PSG. If this is positive, they will have APAP
           treatment. If both the PM and PSG are negative for OSA the patient exits the study but
           will be followed in sleep clinic.

        3. PSG for CPAP titration (PSG arm only).

        4. CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional
           Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory
           therapist will setup the units, fit masks, and instruct the patients on the use of their
           device. Patients being treated with CPAP or APAP will be in separate classes.

        5. Telephone contact within 7 days of setup with early intervention for PAP problems if
           needed.

        6. Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ,
           and PAP satisfaction questionnaire.
    

Intervention name(s): Continuous positive airway pressure; Auto-adjusting positive airway pressure treatment
Intervention type(s): Device; Device
Intervention description(s): continuous positive airway pressure determined by polysomnography titration; Pressure range 4-18 centimeters of water (cm H2O)
Other intervention name(s): CPAP; AutoCPAP; APAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep apnea; positive airway pressure; portable monitoring; auto positive airway pressure