Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
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.
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.
Inclusion Criteria:

 -  OSA, Apnea-hypopnea index > 5/hour

 Exclusion Criteria:

 -  Prior CPAP

 -  Uncontrolled Depression

 -  Moderate to Severe chronic obstructive pulmonary disease (COPD)

 -  Hypoventilation

 -  Average estimated nightly total sleep time < 4 hours

 -  Shift work

 -  Unstable depression

 -  Upper airway surgery

 -  Uncontrolled Restless legs syndrome (RLS), narcolepsy

 -  Use of supplemental oxygen

 -  Severe congestive heart failure

 -  Use of nightly potent narcotics

 -  Severe obesity (BMI > 40)