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

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: Continuous positive airway pressure
Device: Auto-adjusting positive airway pressure treatment

Registration Number: NCT00988351

Lead Sponsor: North Florida Foundation for Research and Education

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 156

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSG CPAP titration then CPAP treatment	Continuous positive airway pressure	Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Auto-Adjusting Positive Airway Pressure	Auto-adjusting positive airway pressure treatment	Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.

Primary Outcome Measures

Name	Time	Method
Positive Airway Pressure Adherence (Nightly Use of Treatment)	6 weeks after starting treatment	average nightly hours of using positive airway pressure (including 0 for nights not used)

Secondary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale	6 weeks after starting treatment	Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.
Change in Functional Outcomes of Sleep Questionnaire	6 weeks at clinic	The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.
Residual Apnea-hypopnea Index	over first 6 weeks of treatment	The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI \< 10 is considered adequate treatment and \<5/hour ideal treatment.
Treatment Pressure (Level of CPAP or 90th Percentile APAP)	6 weeks clinic	The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.