Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP.
We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of the Evolution of Memory Deficit in Patients With Sleep Apnea Obstructive Syndrome (SAOS) Before and After "Effective" Versus Sham Treatment by Positive Pression Continues (PPC)|
|Study Start Date:||April 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Effective CPAP treatment
Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks
Device: Effective CPAP
Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water
Sham Comparator: Sham CPAP treatment
Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
Device: Sham CPAP
Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464659
|Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory|
|Grenoble, Isere, France|
|Principal Investigator:||Jean-Louis JP Pépin, ProfessorPhD||University Hospital, Grenoble|