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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT00988351

Run by

North Florida Foundation for Research and Education

People needed

156

Starts

2010-02-01

Expected to finish

2012-12-01

Last updated by the study team

2014-11-03

Who can join

Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• OSA, Apnea-hypopnea index > 5/hour

You may not qualify if…

• 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)

Where it is running

• Malcom Randall VA Medical Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.