Clinical trial NCT00988351: Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
Official title: Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
positive airway pressure
portable monitoring
auto positive airway pressure
Lead sponsor: North Florida Foundation for Research and Education
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Positive Airway Pressure Adherence (Nightly Use of Treatment)
timeFrame: 6 weeks after starting treatment
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale
timeFrame: 6 weeks after starting treatment
measure: Change in Functional Outcomes of Sleep Questionnaire
timeFrame: 6 weeks at clinic
measure: Residual Apnea-hypopnea Index
timeFrame: over first 6 weeks of treatment
measure: Treatment Pressure (Level of CPAP or 90th Percentile APAP)
timeFrame: 6 weeks clinic
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: University of Florida/Malcom Randall VAMC
name: Richard B Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: